| Hepatitis B |
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| Disease Issues |
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| What are the
signs and symptoms of hepatitis B? |
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| About 30%–50%
people who are 5 years of age or older with
acute (recently acquired) hepatitis B have
initial signs or symptoms when infected with
hepatitis B virus (HBV). Children younger than
age 5 years and newly infected
immunosuppressed adults rarely show any
symptoms. When present,
signs and symptoms of hepatitis B might
include nausea, lack of appetite, tiredness,
muscle, joint, or abdominal pain, fever,
diarrhea or vomiting,
headache, dark urine, clay-colored stools, and
yellowing of the skin and whites of the eyes
(jaundice). People who have such signs or
symptoms generally
feel quite ill and might need to be
hospitalized. In 2018, an estimated 21,600 new
HBV infections occurred, with the highest
rates of reported acute cases
among adults 30 through 49 years of age. A
total of 1,649 hepatitis B-related deaths were
reported, with 57% of deaths occurring among
adults 55 through
74 years of age. People with chronic
(life-long) HBV infection might have no
symptoms, have no evidence of liver disease,
or have a range of disease
from chronic hepatitis to cirrhosis or
hepatocellular carcinoma, a type of liver
cancer. |
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| How long does
it take to show signs of illness after a
person becomes infected with HBV? |
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| If signs or
symptoms of illness occur, they begin an
average of 90 days (range: 60–150 days) after
exposure to HBV. |
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| How is
hepatitis B virus (HBV) transmitted? |
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| Persons with
chronic HBV infection (those with persistent
hepatitis B surface antigen [HBsAg] in the
serum for at least 6 months) serve as the main
reservoir for HBV transmission. |
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| HBV is
transmitted through percutaneous (through the
skin), mucosal, or non-intact skin exposure to
infectious blood or body fluids. HBV is
concentrated
most highly in blood, and percutaneous
exposure is an efficient mode of transmission.
Semen and vaginal secretions are infectious,
and HBV also can be
detected in saliva, tears, and bile. Cerebrospinal fluid, synovial fluid, pleural
fluid, peritoneal fluid, pericardial fluid,
and amniotic fluid are also considered
potentially infectious. Urine, feces, vomitus,
nasopharyngeal washings, sputum, and sweat are
not efficient vehicles of transmission unless
they contain
blood because they contain low quantities of
infectious HBV. Hepatitis B surface antigen (HBsAg)
found in breast milk is also unlikely to lead
to
transmission so HBV infection is not a
contraindication to breastfeeding. |
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| Among adults in
the U.S., HBV is transmitted primarily by
percutaneous exposure to blood (for example,
injection drug use) and sexual contact. HBV is
transmitted efficiently by sexual contact both
among heterosexuals and among men who have sex
with men (MSM). Risk factors for sexual
transmission
among heterosexuals include having unprotected
sex with an infected partner, having
unprotected sex with more than one partner,
and a history of another
sexually transmitted infection (STI). |
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| Risk factors
associated with sexual transmission among MSM
include having multiple sex partners, history
of another STI, and anal intercourse.
Transmission can occur from interpersonal
contact (e.g., sharing a toothbrush or razor,
contact with exudates from dermatologic
lesions, or contact with
HBsAg-contaminated surfaces) and in settings
such as schools, child care centers, and
facilities for developmentally disabled
persons.
Transmission of HBV from transfusion of blood
or blood products is rare because of donor
screening and viral inactivation procedures.
Other possible
sources of infection include contaminated
medical or dental instruments, unsafe injections, needle-stick injuries, organ
transplantation, and dialysis. |
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| More of my
patients are getting tattoos and body
piercings. Should they be concerned about
contracting a bloodborne infection like HBV? |
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| Yes. Even though
tattooing and body piercing are not thought to
be a significant mode of transmission for HBV, tattooing and body piercing have the
potential to transmit bloodborne infections,
including HBV, hepatitis C virus (HCV), and
human immunodeficiency virus (HIV), if the
person doing the
tattoos or body piercing does not use good
infection control practices. The Centers for
Disease Control and Prevention (CDC)
recommends that
instruments or materials (including ink),
intended to penetrate the skin be used once,
then disposed of or thoroughly cleaned and
sterilized between
clients. Personal service workers who do
tattooing or body piercing should be educated
about the transmission of bloodborne pathogens
and what
precautions are needed to prevent transmission. |
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| People
considering getting a tattoo or having a body
part pierced should ask staff at the
establishment what procedures they use to
prevent the spread of
bloodborne infections. They also might call
the local health department to find out what
sterilization procedures are required by law
or ordinance for
tattooing and body piercing establishments. |
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| What is the
risk for transmitting HBV by oral sex? |
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| There are no
specific data on transmission of bloodborne
viruses through oral-genital sex. Saliva has
not been associated with HBV transmission
unless
biting has taken place. HBV is not spread by
kissing, hugging, sneezing, coughing, food or
water, sharing eating utensils or drinking
glasses, or casual
contact. |
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| If a patient
is diagnosed with acute hepatitis B and then
resolves the infection, can the patient ever
get hepatitis B again? |
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| Generally
speaking, no. A person with laboratory
evidence of resolved hepatitis B infection is
considered immune. Vaccination of such
individuals is not harmful but is not
necessary. |
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| How stable is
HBV in the environment? What types of
equipment cleaners are effective against HBV? |
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| HBV is stable in
the environment and remains viable for 7 or
more days on environmental surfaces at room temperature. HBV can be transmitted despite
the absence of visible blood. Any high level
disinfectant that is tuberculocidal will
inactivate HBV. The Environmental Protection
Agency also registers
disinfectants specifically approved for use
against HIV and HBV; a current list is
available at this website:
www.epa.gov/pesticide-registration/list-d-epas-registered-antimicrobial-products-effective-against-human-hiv-1 |
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| What are
the various serologic tests for hepatitis B? |
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| Table
1: Hepatitis B laboratory nomenclature |
| HBsAg: |
Hepatitis
B surface antigen is a marker of infectivity.
Its presence indicates either acute or chronic
HBV infection. |
| anti-HBs: |
Antibody
to hepatitis B surface antigen is a marker
of immunity. Its presence indicates an immune response
to HBV infection, an immune response to vaccination,
or the presence of passively acquired antibody.
(It is also known as HBsAb, but this
abbreviation is best avoided since it is often
confused with abbreviations such as HBsAg.) |
| anti-HBc
(total): |
Antibody
to hepatitis B core antigen is a nonspecific
marker of acute, chronic, or resolved HBV infection.
It is not a marker of vaccine-induced immunity.
It may be used in prevaccination testing to determine
previous exposure to HBV infection. (It is also
known as HBcAb, but this abbreviation
is best avoided since it is often confused with
other abbreviations.) |
| IgM
anti-HBc: |
IgM antibody
subclass of anti-HBc. Positivity indicates
recent infection with HBV (<6 mos). Its
presence indicates acute infection. |
| HBeAg: |
Hepatitis
B "e" antigen is a marker of a high
degree of HBV infectivity, and it correlates with
a high level of HBV replication. It is primarily
used to help determine the clinical management
of patients with chronic HBV infection. |
| Anti-HBe: |
Antibody
to hepatitis B "e" antigen may be
present in an infected or immune person. In persons
with chronic HBV infection, its presence suggests
a low viral titer and a low degree of infectivity. |
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HBV-DNA: |
HBV Deoxyribonucleic acid is a
measure of viral load and reflects viral
replication. It correlates well with
infectivity. It is used to assess and
monitor the
treatment of patients with chronic HBV
infection. |
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| How do I
interpret some of the common hepatitis B panel results? |
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| Table 2 |
| Tests |
Results |
Interpretation |
Vaccinate? |
HBsAg
anti-HBc
anti-HBs |
negative
negative
negative |
susceptible |
vaccinate
if indicated |
HBsAg
anti-HBc
anti-HBs |
negative
negative
positive with >10mIU/mL* |
immune
due to vaccination (or may represent passive transfer of antibodies from receipt of HBIG) |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
negative
positive
negative
positive |
immune
due to natural infection |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
negative
positive
positive
positive |
acute resolving infection |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
positive
positive
positive
negative |
acutely
infected |
no
vaccination necessary |
HBsAg
anti-HBc
IgM anti-HBc
anti-HBs |
positive
positive
negative
negative |
chronically
infected |
no
vaccination necessary (may need treatment) |
HBsAg
anti-HBc
anti-HBs |
negative
positive
negative |
four
interpretations possible† |
use
clinical judgment |
| * |
Postvaccination testing, when it is recommended,
should be performed 1-2 months after the last dose of
vaccine. Infants born to HBsAg-positive mothers should
be tested for HBsAg and anti-HBs after completion of
at least 3 doses of a licensed hepatitis B vaccination
series, at age 9-18 months (generally at the next well
child visit). |
| †1. |
May be distantly immune, but the test
may not be sensitive enough to detect
a very low level of anti-HBs in serum |
| 2. |
May be susceptible with a false
positive anti-HBc |
| 3. |
May be chronically infected and have
an undetectable level of HBsAg present
in the serum |
| 4. |
Passive transfer of antibody following HBIG administration or from an HBsAg-positive mother to her newborn |
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| Who should be
tested for anti-HBs after vaccination? |
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| Serologic testing
for immunity is not necessary or recommended
after routine vaccination of infants,
children, or adults. Testing for anti-HBs
after
vaccination is recommended for the following
groups whose subsequent clinical management
depends on knowledge of their immune status: |
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| • |
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Infants born to HBsAg-positive women and infants born to
women whose HBsAg status remains unknown
(for example, infants surrendered
shortly after birth); postvaccination
serologic testing should consist of testing
for anti-HBs and HBsAg |
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| • |
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Healthcare
professionals and public safety workers at
risk for blood or body fluid exposure |
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| • |
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Hemodialysis
patients (and other persons who might
require outpatient hemodialysis),
HIV-infected persons, and other
immunocompromised
persons (such as hematopoietic stem-cell
transplant recipients or persons receiving
chemotherapy), to determine the need for
revaccination and the type
of follow-up testing, and |
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| • |
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Sex partners of HBsAg-positive persons, to determine if they
have not achieved immunity and will need revaccination and to continue to use
other methods of protection against HBV
infection. |
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| Testing should be
performed 1–2 months after administration of
the final dose of the vaccine series using a
method that allows determination of a
protective
concentration of anti-HBs (10 mIU/mL or
higher). |
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| I have a
patient who is positive for anti-HBc
(hepatitis B core antibody) but negative for
all other hepatitis B serologic markers.
Should he receive hepatitis
B vaccine? |
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| Some isolated
positive anti-HBc results are false positives
(it is the most common false positive HBV
marker). If that can be established, the
individual can
and likely should be vaccinated, assuming
there is an indication or desire to be
protected. If the positive anti-HBc is
believed to be a true positive, the
individual would not require vaccination since
they have already (presumably) had HBV
infection. Isolated positive anti-HBc could
indicate low-level
chronic infection. In an infant isolated anti-HBc
could indicate passive transfer of antibody
from a mother who is HBsAg positive. People
found to be anti-HBc positive should be tested for HBsAg. HBsAg
testing may be performed on the same specimen
collected for anti-HBc testing. If the HBsAg
test result is
positive, the person is infected and should
receive appropriate management. |
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| I work in a
dialysis unit. Our lab reports anti-HBs
results as adequate or inadequate, rather than providing a quantitative result. Is this
acceptable? |
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| Reporting of
adequate and inadequate is acceptable only if
your lab is using mIUs as the measurement for
anti-HBs and the cutoff is below 10 mIU for
reporting inadequate anti-HBs and 10 mIU or
higher for reporting adequate anti-HBs. You
should check with your lab to be certain this
is being done. |
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| We did a
hepatitis B panel for a new hospital employee
from Gambia. She had no documentation of
having been vaccinated. Her results showed HBsAg
nonreactive, anti-HBc reactive, IgM anti-HBc
nonreactive, and anti-HBs borderline. We don't
know how to interpret these results. Should
she be
immunized? |
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| Most likely this
person has a resolved hepatitis B infection
and is immune. However, it would be preferable
to test her again for all these serologic
markers,
and also quantify the anti-HBs result. If the
results are still positive for anti-HBc, and
anti-HBs is less than the immune level of 10
mIU/mL, you can give her
one dose of hepatitis B vaccine and test again
in 1–2 months. If the anti-HBs is positive (10
mIU/mL or higher), she is immune. No further
action is needed
other than to document the results. If the
anti-HBs is still negative, complete the
vaccine series and test again 1–2 months after
the last dose of vaccine. |
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| Where can I
locate CDC's recommendations for hepatitis B
vaccination? |
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| The most recent
comprehensive recommendations for hepatitis B
vaccination were published in January 2018.
The document is available at
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF.
Recommendations for the use of adjuvanted
hepatitis B vaccine (Heplisav-B, Dynavax) were
published in April 2018 and are available at
www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6715a5-H.pdf. |
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| Please
describe the currently available hepatitis B
vaccines. |
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| All hepatitis B
(HepB) vaccines currently available in the
United States contain recombinant hepatitis B
surface antigen (HBsAg) produced in yeast
cells.
Hepatitis B vaccines are available as a
single-antigen formulation and in combination
with other vaccines. Of the three single
antigen HepB vaccines
available in the United States, Engerix-B
(GlaxoSmithKline) and Recombivax HB (Merck)
are approved for vaccination starting at
birth. Heplisav-B
(Dynavax) is approved only for people 18 years
of age and older. |
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| Engerix-B and
Recombivax HB are available in both pediatric
and adult formulations. For the 3-dose series
of both vaccines, people 0 through 19 years of
age receive a 0.5 mL dose regardless of their
height or weight. People 20 years of age and
older receive a 1.0 mL dose. |
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| Three combination
vaccines that contain HepB are, or soon will
be, available in the United States. Pediarix (GlaxoSmithKline) is approved for children 6
weeks through 6 years of age and contains
HepB, DTaP, and inactivated poliovirus. Twinrix (GlaxoSmithKline) is approved for
persons 18 years of age and
older and contains HepB and inactivated
hepatitis A virus. Vaxelis ((MCM Company) is
approved for use in children 6 weeks through 4
years of age and
contains HepB, DTaP, Hib, and IPV and is
expected to be commercially available sometime
in 2021. Comvax (Merck), a combination vaccine
that
contained HepB and Haemophilus influenzae type
b, was discontinued in 2014 in the United
States. |
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| The adult
formulation of Engerix-B contains twice as
much antigen per dose as the adult
formulations of Recombivax HB. If a patient
received 10 mcg (1 mL) of Recombivax for the
first dose, and I stock only Engerix-B, should
I give a 10 mcg (0.5 mL) dose of Engerix-B for
subsequent doses? |
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| No. It is the
volume of the dose, not the antigen content,
that is important. Persons 20 years and older
should always receive a 1.0 mL dose of either
Engerix-B or Recombivax HB. Likewise, persons
younger than 20 years should always receive a
0.5 mL dose of the pediatric formulation of
either Engerix-B or Recombivax HB. |
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| Please provide
information about Heplisav-B. |
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| Heplisav-B was
approved by the Food and Drug Administration
in November 2017 for persons 18 years of age
and older. Heplisav-B contains a novel
adjuvant (CpG 1018) that binds to Toll-like
receptor 9 to stimulate the immune response to HBsAg. It is provided in a single dose 0.5 mL
vial and given as a
2-dose series with doses separated by 1 month. |
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| Heplisav-B was
approved based on clinical trials that
compared seroprotection rates (SPR, defined as
anti-HBs of 10 mIU or higher, and indicative
of
protection against hepatitis B infection)
following 2 doses of Heplisav-B to rates following 3 doses of Engerix-B
(GlaxoSmithKline). Among people 18
through 70 years of age, SPRs were 90%–95%
following 2 doses of Heplisav-B and 65%–81%
following 3 doses of Engerix-B. Local
reactions were most
commonly reported (injection site pain,
redness, and swelling) and were similar in
frequency to those following Engerix-B. |
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| What is the
schedule for hepatitis B vaccine? |
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| Heplisav-B is
administered intramuscularly on a 2-dose
schedule with doses separated by 1 month.
Primary vaccination with Engerix-B, Recombivax
HB,
or Twinrix consists of three intramuscular
doses administered on a 0-, 1-, and 6-month
schedule.
Alternative vaccination schedules for Engerix-B
and Recombivax HB (for example, 0, 1, and 4
months or 0, 2, and 4 months) have been
demonstrated to
elicit dose-specific and final rates of seroprotection similar to those obtained on a
0-, 1-, and 6-month schedule. Increasing the
interval between the first 2
doses has little effect on immunogenicity or
the final antibody concentration. The third
dose confers the maximum level of seroprotection and provides
long-term protection. |
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| Recombivax HB may
be administered in a 2-dose schedule at 0 and
4–6 months for adolescents 11 through 15 years
of age using the adult formulation
(1.0 mL). Pediarix is administered at ages 2,
4, and 6 months; it is not used for the birth
dose. Twinrix may be administered on an
accelerated 4-dose
schedule at 0, 7, and 21–30 days, followed by
a dose at 12 months. |
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| Hepatitis B
vaccination of adult (20 years old and older)
hemodialysis patients consists of high-dose
(40 µg) Recombivax HB administered on a 0-,
1-, and
6-month schedule or high-dose (2 mL) Engerix-B
administered on a 0-, 1-, 2-, and 6-month
schedule. The Heplisav-B schedule for
hemodialysis patients
is the same as for other adults, two 0.5 mL
doses, separated by 1 month. |
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| If the
vaccination series is interrupted does the
series need to be restarted? |
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| For all ages,
when the HepB schedule is interrupted, the
vaccine series does not need to be restarted.
If the Heplisav-B series is interrupted, the
second
(final) dose should be given as soon as
possible. For Engerix-B and Recombivax HB, if
the series is interrupted after the first
dose, the second dose
should be administered as soon as possible,
and the second and third doses should be
separated by at least 8 weeks. If only the
third dose has been
delayed, it should be administered as soon as
possible. |
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| What are the
minimum intervals between doses in the
hepatitis B vaccine series? |
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| The minimum
interval between the two doses of Heplisav-B
is 4 weeks. For the 3-dose series vaccines,
Engerix-B and Recombivax HB, the minimum
interval between the first and second doses is
4 weeks. The final dose of vaccine must be
administered at least 8 weeks after the second
dose and should
follow the first dose by at least 16 weeks.
Vaccine doses administered 4 or fewer days
before the minimum interval or age are
considered valid. Doses
received 5 or more days before the minimum
interval or age should be repeated using the
correct schedule. Because of the unique
accelerated schedule
for Twinrix, the 4-day "grace period" does not
apply to the first three doses of this vaccine
when administered on a 0-, 7-, 21–30-day, and
12-month
schedule. |
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| We
inadvertently gave a 25-year-old a pediatric
(0.5 mL) dose of Engerix-B. Can we just give
her another pediatric dose or should she
receive a repeat
adult dose? |
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| What you do
depends on when the error is identified. If
the error is discovered while the person is
still in the office, you can administer the
other "half" of
the Engerix-B dose. If the error is discovered
later, the dose should not be counted. The
person should be recalled to the office and
given a full age-appropriate 1.0 mL repeat dose. The same
recommendation would apply if the error was
with Recombivax HB. |
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| Can Heplisav-B
be used to complete a vaccination series
started with Engerix-B or Recombivax HB? |
|
| Yes. However,
data are limited on the safety and
immunogenicity effects when Heplisav-B is
interchanged with hepatitis B vaccines from
other
manufacturers. When feasible, the same
manufacturer's vaccines should be used to complete the series. However, vaccination
should not be deferred
when the manufacturer of the previously administered vaccine is unknown or when the
vaccine from the same manufacturer is
unavailable. |
|
| The 2-dose HepB
series for adults only applies when both doses
in the series consist of Heplisav-B. Series consisting of a combination of 1 dose of
Heplisav-B and a vaccine from a different
manufacturer should consist of 3 total vaccine
doses and should adhere to the 3-dose schedule
minimum
intervals of 4 weeks between dose 1 and 2, 8
weeks between dose 2 and 3, and 16 weeks
between dose 1 and 3. Doses administered at
less than the
minimum interval should be repeated. However,
a series containing 2 doses of Heplisav-B
administered at least 4 weeks apart is valid,
even if the patient
received a single earlier dose from another
manufacturer. |
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| How long is
hepatitis B vaccine protective? |
|
| Studies indicate
that immunologic memory remains intact for at
least 30 years and confers protection against clinical illness and chronic HBV infection,
even though anti-HBs levels that once measured
adequate might become low or decline below
detectable levels. If exposed to HBV, people
whose immune
systems are competent will mount an anamnestic
response and develop protective anti-HBs.
Studies are on-going to assess whether booster doses of
HepB will be needed in the future. |
|
| I tested
positive for chronic HBV infection about 5
months ago. I know there is a vaccine to
prevent transmission, however, I would like to
know how long
my partner should wait after taking this
vaccine, before having sex with me without any
risk of transmission? |
|
| You should use
condoms until a postvaccination blood test
(hepatitis B surface antibody, or anti-HBs)
shows that your partner is protected from HBV
infection. The efficacy of latex condoms in
preventing infection with HBV is unknown, but
their proper use might reduce the risk of
transmission. Your
sexual partner should have the 2- or 3-dose
series of hepatitis B vaccine (depending on
brand) and postvaccination blood testing 1 to
2 months after the
last dose of vaccine. If your partner's test
shows adequate anti-HBs (at least 10 mIU/mL),
then he/she should be protected against HBV
infection. |
|
| Where can I
find out about vaccine shortages? |
|
| For detailed
information about HepB and other vaccine
shortages, go to CDC's website at
www.cdc.gov/vaccines/vac-gen/shortages. |
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| My adult
patient is traveling to Nigeria in three days.
She is already immune to hepatitis A, but we
want to provide protection for hepatitis B.
She received
Twinrix two weeks ago and then a dose of
single-component hepatitis B vaccine one week
ago. How can we best provide protection in
this circumstance? |
|
| Even though ACIP
does not recommend an accelerated HepB
schedule in routine circumstances, a 4-dose
series at 0, 7, 14 days, and 6 months is
acceptable (see
www.cdc.gov/mmwr/PDF/rr/rr5516.pdf,
page 27). Although this schedule deviates from
the routine recommendation it can be used
if travel is imminent. Give a dose of HepB now which will complete 3 of the 4-dose
accelerated schedule. She will need a fourth
and final dose at least 6
months after the first dose in the accelerated
schedule. |
|
| An adolescent
received the first dose of HepB at age 11
years but did not return for subsequent doses.
If the patient comes back at age 16 years, is
it
necessary to repeat the first dose of the
series? |
|
| It is not
necessary to restart or add doses to the HepB
series (or any other routine vaccine series)
because of a prolonged interval between doses.
Just
continue the series from the point where it
was interrupted. Note that the 2-dose Recombivax HB series using the adult
formulation is approved only for
adolescents 11 through 15 years of age. At age
16 years, the schedule reverts to the standard
pediatric formulation 3-dose schedule rather
than 2 adult
doses. |
|
| If you want to
test and vaccinate your patient for hepatitis
B on the same day, does it matter if you test
or vaccinate first? |
|
| Yes. You should
draw the blood first and then administer the
first dose of vaccine, as transient
HBsAg-positivity has been detected after a
dose of HepB
(see next question). |
|
| How long
should a person wait to donate blood or have
an HBsAg blood test after a dose of hepatitis
B vaccine? |
|
| It is advisable
to wait at least 3 weeks. Published studies
have found that transient HBsAg-positivity can
be detected for up to 18 days after HepB
vaccination (up to 52 days among hemodialysis
patients). This does not mean the person is
infected with HBV. However, donating too close
to receipt of
HepB could cause a person to be permanently
deferred from blood donation if that person
tests transiently HBsAg positive after the
vaccine dose. |
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| Where can I
obtain a copy of the most recent
recommendation of the Advisory Committee on
Immunization Practices (ACIP) for the
prevention of
perinatal transmission of HBV infection? |
|
| The January 2018
recommendations are available at
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF. |
|
| Should
pregnant women be vaccinated against hepatitis
B during pregnancy? |
|
| Yes; women who
are identified as being at risk for HBV
infection during pregnancy should be
vaccinated. They also should be counseled
concerning other
methods to prevent HBV infection. Providers
should administer an age-appropriate 3-dose
series of Twinrix, Engerix-B or Recombivax HB.
Until safety data
are available for Heplisav-B administration
during pregnancy, ACIP recommends providers
vaccinate pregnant women needing HepB vaccination with a
vaccine from a different manufacturer. |
|
| What if
Heplisav-B is inadvertently administered to a
pregnant woman? |
|
| There are
insufficient data available to inform
assessment of Heplisav-B vaccine-associated
risks during pregnancy. The manufacturer, Dynavax, does not
consider pregnancy to be a contraindication to
the use of Heplisav-B. Dynavax has established
a Vaccination in Pregnancy Registry in order
to
understand the effect (if any) of Heplisav-B
vaccination during pregnancy. Women who
receive Heplisav-B within 28 days before
pregnancy or at any
time during pregnancy are encouraged to
participate in the registry by calling
1-844-443-7734. |
|
| What is the
schedule for hepatitis B vaccine
administration for infants who weigh less than
2000 grams? |
|
| Decreased
seroconversion rates might occur among preterm
infants with birth weights less than 2,000
grams after administration of HepB at birth.
However, by the chronological age of 1 month,
all preterm infants, regardless of initial
birth weight, are likely to respond as
adequately as larger infants.
Infants who weigh less than 2,000 grams born
to HBsAg-positive women and women with unknown
HBsAg status (if the mother's HBsAg status
cannot be
determined within 12 hours of birth) must
receive immunoprophylaxis with HepB and
hepatitis B immune globulin (HBIG) within 12
hours of birth. The initial
vaccine dose should not be counted toward
completion of the hepatitis B series, and 3
additional doses of HepB should be
administered, beginning when
the infant is age 1 month. Infants weighing
less than 2,000 grams born to HBsAg-negative
mothers should receive the first dose of the
HepB series at
hospital discharge or at chronological age 1
month (even if weight is still less than 2,000
grams), whichever comes first. |
|
| What blood
test should be used to screen a pregnant woman
to prevent perinatal HBV infection? |
|
| Screening should
be done with the hepatitis B surface antigen (HBsAg)
test only. This blood test will tell whether a woman has current HBV infection that
can be transmitted to her infant. Ordering a
total antibody to hepatitis B core antigen
(total anti-HBc) and/or anti-HBs are not
useful when screening to
prevent perinatal HBV infections and should
not be included in screening pregnant women
for perinatal HBV infection. Total anti-HBc
will be positive in all
HBsAg-positive people and anti-HBs is rarely
positive in an HBsAg-positive person. Women
who are found to be positive should be tested
for HBV DNA to
guide the use of maternal antiviral therapy
during pregnancy for the prevention of
perinatal HPV transmission (see MMWR 2018;67
[RR-1]:13). |
|
| An infant born to
a woman for whom HBsAg screening test results
during pregnancy are not available but other evidence suggesting maternal HBV
infection exists (e.g., presence of HBV DNA,
HBeAg-positive, or mother known to be
chronically infected with HBV) should be
managed as if born to an
HBsAg-positive mother. The infant should receive both HepB and HBIG within 12 hours of
birth. The woman should also be referred to
her jurisdiction's
Perinatal Hepatitis B Prevention Program for
case management to ensure that their infants
receive timely prophylaxis and follow-up. |
|
| Do women who
have been vaccinated previously against HBV
infection still need to be screened during pregnancy? |
|
| Yes. Women who
have received HepB should still be screened
for HBsAg early in each pregnancy. Just
because a woman has been vaccinated does not
mean she is HBsAg negative. Since
postvaccination testing is not performed for
most vaccinated people, she could have been
vaccinated even though she
was already actively infected. |
|
| I've
identified a patient in my obstetrical
practice who is HBsAg positive. Should she be
evaluated for liver disease during her
pregnancy, or should the
evaluation wait until the postpartum period?
What should I recommend for her husband and
her children? How urgent is the time frame? |
|
| The earlier the
evaluation is done, the better. Consultation
with or referral to a liver disease specialist
(such as a hepatologist, gastroenterologist,
or
infectious disease specialist) should be done.
The consulting/referral physician should be
aware of the patient's obstetrical status. In
addition, the patient's
sex partner and children or other household
contacts should be tested for HBV infection
(total anti-HBc and HBsAg) as soon as
possible. If any are
susceptible to HBV infection (total anti-HBc
and HBsAg negative), they should be
vaccinated. If any are HBsAg positive, they
should be referred to or have
consultation with a liver disease specialist. |
| |
| If a mother's
HBsAg test result is not available at the time
of birth, how should the infant be managed? |
|
| • |
|
Infants born to women for whom HBsAg
testing results during pregnancy are not
available but other evidence suggestive
of maternal HBV
infection exists (for example presence
of HBV DNA, HBeAg-positive, or mother known to be chronically infected with
HBV) should be managed as if born
to an HBsAg-positive mother. |
|
|
|
| • |
|
Women
admitted for delivery without
documentation of HBsAg test results
should have blood drawn and tested as
soon as possible after
admission. |
|
|
|
| • |
|
While test
results are pending, all infants with
birth weights of 2,000 grams or more
born to women without documentation of HBsAg test results
should receive the first dose of
single-antigen HepB (without HBIG)
within 12 hours of birth. Only single
antigen HepB vaccine should be used for
the birth
dose. |
|
|
|
| • |
|
If the mother is determined to be HBsAg
positive, her infant should receive HBIG
as soon as possible but no later than
age 7 days, and the
vaccine series should be completed
according to a recommended schedule for infants born to HBsAg-positive mothers. |
|
|
|
| • |
|
If the mother is determined to be HBsAg
negative, the vaccine series should be
completed according to a recommended
schedule for infants
born to HBsAg-negative mothers. |
|
|
| For preterm
infants, see the next question. |
|
| Please review
the hepatitis B vaccination recommendations
for preterm infants who weigh less than 2,000 grams (4.4 pounds), as well as for those
premature infants who weigh more. |
|
Preterm infants
weighing less than 2,000 grams (4.4 pounds) at
birth have a decreased response to HepB administered before age 1 month. By age 1
month, medically stable preterm infants,
regardless of initial birth weight or
gestational age, have an immunologic response
to HepB vaccination that is
comparable to that of full-term infants. For
preterm infants weighing less than 2,000 grams
at birth:
|
|
|
|
| • |
|
|
If maternal HBsAg status is positive: |
|
|
|
|
| |
– |
|
Give hepatitis B immune globulin (HBIG)
plus HepB vaccine within 12 hours of
birth. The birth dose (the initial
HepB dose) should not be counted
as part of the vaccine series. |
|
|
|
|
| |
– |
|
Give 3 additional HepB doses (for a
total of 4 doses) at ages 1, 2 to 3,
and 6 months, or HepB-containing combination vaccine (Pediarix) at ages
2, 4, and 6 months. The final dose
should not be administered before 24
weeks of age. |
|
|
|
|
| |
– |
|
Test for HBsAg and anti-HBs at age
9–12 months, or 1–2 months after the
final dose of the vaccine series if completion of the series is delayed.
Testing should not be performed before
age 9 months (anti-HBs resulting from
use of HBIG might still be positive
and therefore misleading) or within 1
month of the most recent HepB dose
(testing for HBsAg sooner than 1 month
of a vaccine dose might produce a
transient HBsAg-positivity). |
|
|
|
|
| • |
|
|
If maternal HBsAg status is unknown: |
|
|
|
|
| |
– |
|
If the mother's HBsAg status cannot be
determined within 12 hours of birth
give HBIG plus HepB vaccine. The birth
dose of vaccine should not
be counted as part of the 3 doses
required to complete the HepB series. |
|
|
|
|
| |
– |
|
Three additional doses of vaccine (for
a total of 4 doses) should be
administered according to the recommended schedule on the basis of
the
mother's HBsAg test result. The final
dose in the series should not be
administered before 24 weeks of age. |
|
|
|
|
| • |
|
|
If it
is not possible to determine the
mother's HBsAg status: |
|
|
|
|
| |
– |
|
The
vaccine series should be completed
according to a recommended schedule
for infants born to HBsAg positive
mothers. |
|
|
|
|
| • |
|
|
If the
maternal HBsAg status is negative: |
|
|
|
|
| |
– |
|
If you
are certain that appropriate maternal
testing was done and a copy of the
mother's original laboratory report
indicating that she was HBsAg
negative during this pregnancy is
placed on the infant's chart, delay
the first dose of HepB vaccine until
age 1 month or hospital discharge
(even if weight
is still less than 2,000 grams),
whichever comes first. Complete the
vaccine series per the recommended
schedule. |
|
|
| For preterm
infants weighing 2,000 grams or more at birth,
follow the recommendations for full-term
infants including a HepB dose within 24 hours
of birth. |
|
| What is the
recommended time to do hepatitis B testing for
evidence of success or failure of immunoprophylaxis given at birth to an infant
born to a
hepatitis B surface antigen (HBsAg)-positive
mother? |
|
| In 2015, CDC
revised the recommendation for the timing of
hepatitis B serologic testing for infants born
to an HBsAg-positive woman. Postvaccination
testing (HBsAg and hepatitis B surface
antibody [anti-HBs]) is now recommended 1 to 2
months after completion of at least three
doses of the HepB
vaccine series, but not before 9 months of
age. For a child vaccinated on schedule,
testing should be done at age 9 to 12 months.
Testing should not be
performed before age 9 months because
hepatitis B immune globulin (HBIG) might still
be present at age 6 to 8 months, nor should
testing be performed
within 1 month of the most recent HepB dose
because a transient false positive HBsAg might
occur. Antibody to hepatitis B core (anti-HBc)
testing of
infants or children is not recommended because
passively acquired maternal anti-HBc might be
detected up to age 24 months in children of
HBV-infected
mothers. Children who are HBsAg positive
should receive medical evaluation and ongoing
follow-up. For additional information, see
www.cdc.gov/mmwr/pdf/wk/mm6439.pdf, pages
1118–20. |
|
| How should I
manage an infant of an HBsAg-positive mother
who tests negative for anti-HBs after 3 properly spaced doses of vaccine? |
|
| HBsAg-negative
infants with anti-HBs levels 10 mIU/mL or
higher are protected and need no further
medical management. HBsAg-negative infants
with
anti-HBs less than 10 mIU/mL should be
revaccinated with a single dose of hepatitis B
vaccine and receive postvaccination serologic
testing 1–2 months
later. Infants whose anti-HBs remains less
than 10 mIU/mL following single dose
revaccination should receive 2 additional
doses of HepB to complete the
second series, followed by postvaccination
serologic testing 1–2 months after the final
dose. |
|
| Based on clinical
circumstances or family preference, HBsAg-negative
infants with anti-HBs less than 10 mIU/mL may
instead be revaccinated with a
second, complete 3-dose series, followed by
postvaccination serologic testing performed
1–2 months after the final dose of vaccine. |
|
| What should I
do if an infant tests negative for anti-HBs
after 2 complete vaccine series? |
|
| Available data do
not suggest a benefit from administering
additional HepB vaccine doses to infants who
have not attained anti-HBs of mIU/mL or higher
following receipt of two complete HepB series.
HBsAg-positive infants should be referred for
appropriate follow-up with a physician who
specializes in
evaluating infants with liver disease. |
|
| Is it safe for
an HBsAg-positive mother to breastfeed her
infant? |
|
| Yes. An HBsAg-positive
mother who wishes to breastfeed should be
encouraged to do so, including immediately following delivery. However, the infant
should receive HBIG and HepB vaccine within 12
hours of birth. Although HBsAg can be detected
in breast milk, studies done before HepB was
available
showed that breastfed infants born to HBsAg-positive
mothers did not demonstrate an increased rate
of perinatal or early childhood HBV infection. More
recent studies have shown that, among infants
receiving post-exposure prophylaxis to prevent
perinatal HBV infection, there is no increased
risk of
infection among breastfed infants. |
|
| Can Pediarix
be given at birth? |
|
| No. Pediarix
should not be given before age 6 weeks of age
because it can result in suppression of the
immune response to the acellular pertussis
component. |
|
| If I want to
use Pediarix is it acceptable to give a 4-dose
schedule of hepatitis B vaccine to infants? |
|
| Yes. The use of a
4-dose HepB schedule is acceptable when giving
the monovalent HepB vaccine birth dose followed by the use of Pediarix. The use of a
4-dose HepB schedule, including schedules with
a birth dose, has not increased vaccine reactogenicity and results in higher final
antibody titers that
should correlate with longer duration of
detectable antibody. The federal Vaccines for
Children (VFC) program provides up to four
doses of HepB for
VFC-eligible children. You may still use
monovalent HepB in a 3-dose series. |
|
| We give HepB
vaccine to newborns in the hospital followed
by Pediarix at 2, 4, and 6 months of age, so
our patients get 4 doses of HepB. For some
children, the Pediarix dose #3 is delayed and
given closer to 5 months of age, so the
interval is less than 8 weeks between dose #3
and #4 of the HepB
component of Pediarix. |
|
| We are
receiving conflicting information about
whether their HepB vaccine dose #4 is a valid
final dose because of the shortened interval
between dose #3
and #4. Our electronic health record says dose
#4 is valid (regardless of the short interval
from dose #3) but the health department says
it is not. Which is
correct? |
|
| According to
subject matter experts at CDC, your electronic
health record is correct. The CDC website
states that HepB dose #4, if given, must be at
24
weeks of age or later, at least 16 weeks from
dose #1, and at least 8 weeks from dose #2.
There is no minimum interval requirement
between dose #4 and
the previous dose. This information is not
published in any current ACIP statement but it
can be found under "Hepatitis B" at
www.cdc.gov/vaccines/programs/cocasa/reports/algorithm-ref.html. |
|
| An infant was
vaccinated with monovalent HepB at birth.
Later we gave her monovalent HepB at age 1 month and age 4 months. Did we give her the
third
dose too early? |
|
| Yes. Poorer
immune response rates are seen in infants who
complete the vaccination series prior to age 6
months. Do not count dose #3, which you gave
at age 4 months. Repeat dose #3 when the
infant is at least 6 months of age (no earlier
than age 24 weeks). |
|
| If an infant
got a dose of the adult formulation of HepB in
error, should the dose be counted? When should the next dose be scheduled for this infant? Do
we need to be concerned about a possible
adverse event? |
|
| If an infant
received an adult dose of HepB (contains twice
the antigen in a dose of the pediatric
formulation), the dose can be counted as valid
and does
not need to be repeated. Hepatitis B vaccines
are very safe vaccine and no unusual adverse
events would be expected because of this
administration
error. The next (age appropriate) dose should
be given on the usual schedule. |
|
| The recommended
age for the last dose of HepB in an infant is
6 months. |
|
| What is the
earliest age the last dose can be given to an
infant? |
|
| The minimum age
for the last dose of HepB is age 24 weeks (the
minimum age is the youngest age that is acceptable for giving a vaccine and having it
"count" as a valid dose.) This allows
healthcare providers more flexibility in
administering HepB should a parent bring an
infant in for a well-baby check
before the infant reaches a full 6 months of
age. If the third dose is given prior to age
24 weeks the dose should not be counted.
Poorer response rates
are seen in infants who complete the
vaccination series prior to age 24 weeks. The
third dose should be repeated when the infant
is at least age 24 weeks. |
|
|
|
|
|
| Should all
children age 0 through 18 years be vaccinated
against hepatitis B? |
|
| Yes. CDC
recommends that all children age 0 through 18
years be fully vaccinated against hepatitis B.
This recommendation is also endorsed by AAP
and
AAFP and is published as part of the annual
Recommended Childhood and Adolescent
Immunization Schedule
(www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html).
Vaccination should be initiated for children
and teenagers not previously vaccinated and
vaccination completed for all those whose
vaccine series is incomplete. |
|
| All children and
adolescents younger than age 19 years
(including internationally adopted children)
who were born in Asia, the Pacific Islands,
Africa, or
other intermediate or high-endemic countries
or who have at least one parent who was born
in a high-endemic area should be tested for HBsAg and
should complete the vaccine series if they
were not previously vaccinated or were
incompletely vaccinated. |
|
| Can
adolescents be immunized on a 0-, 2-, 4-month
schedule for hepatitis B? |
|
| Yes. There are
data that show adequate seroprotection using
this schedule in young adults. If this
schedule is used, you should be aware that the
studies
were in young adults and might not translate
to older adults (age 40 years or older). There
are other schedules that offer flexibility in
vaccination as well.
View
www.immunize.org/catg.d/p2081.pdf for a
review of different schedules. |
|
| Three years
ago at a middle school, my patient received
the first dose of the HepB series. Should I
give her the second dose now or do I need to
start
over again with the first dose? |
|
| There is no need
to restart the series. Give the second dose of
HepB now and be sure there are at least 8
weeks between that dose and the third dose.
Increasing the interval between the first two
doses has little effect on immunogenicity or
final antibody concentration. The third dose
confers the maximum
level of seroprotection but acts primarily as
a booster and appears to provide optimal
long-term protection. Longer intervals between
the last two doses
result in higher final antibody levels but
might increase the risk for acquisition of HBV
infection among people who have a delayed
response to vaccination.
No differences in immunogenicity have been
observed when one or two doses of hepatitis B
vaccine produced by one manufacturer are
followed by doses
from a different manufacturer. |
|
| Describe the
2-dose regimen for hepatitis B vaccine for
certain young adolescents. |
|
| For the 2-dose
adolescent schedule, the adult dose of
Recombivax HB (1.0 mL dose) is administered to
adolescents age 11 through 15 years, with the
second dose given 4 to 6 months after the
first dose. In immunogenicity studies, antibody concentrations and end seroprotection
rates (at least 10 mIU/mL
of anti-HBs) were similar with the 2-dose schedule and the 3-dose schedule (0.5 mL
dose). As with other HepB vaccination
schedules, if administration of
the 2-dose schedule is interrupted, it is not
necessary to restart the series. Children and
adolescents who have begun vaccination with a
pediatric (0.5 mL)
dose of Recombivax HB should complete the
3-dose series with this dose. If it is not
clear which dose an adolescent was
administered at the start of a
series, the series should be completed with the 3-dose schedule. Heplisav-B, the 2-dose
HepB vaccine given with a 4-week interval
between doses, is
licensed only for adolescents and adults
beginning at age 18 years. |
|
| How should we
complete the series if a 12-year-old starts
the 2-dose Recombivax HB adult formulation series but fails to receive dose 2 before his
or her
16th birthday? |
|
| The 2-dose
Recombivax HB schedule is only approved for
use in children age 11 through 15 years. A
16-year-old child would need two additional
doses of
pediatric HepB to complete a 3-dose series. |
|
| I am confused
about the volume of hepatitis B vaccine dose
to give an adolescent. Is it 0.5 mL or 1.0 mL? |
|
| The dosage
depends on the schedule and manufacturer of
the vaccine that you are using. For children
11 through 15 years of age, the 2-dose
Recombivax HB volume is 1.0 mL. Otherwise the
3-dose schedule of Recombivax HB or Engerix B
is 0.5 mL through age 19 years. Heplisav-B,
the 2-dose
HepB vaccine given with a 4-week interval between 0.5 mL doses, is licensed for
adolescents and adults beginning at age 18
years. IAC offers a handy
resource with charts detailing the correct
dosages and schedules for monovalent hepatitis
B and hepatitis A vaccines and combination
products that
include hepatitis A and hepatitis B vaccines.
Go to
www.immunize.org/catg.d/p2081.pdf. |
|
| I have some
Asian and African children and teens in my
practice who were born abroad. Should I test them all for hepatitis B, or just make sure
they are
all vaccinated? |
|
| All foreign-born
people (including immigrants, refugees, asylum
seekers, and internationally adopted children) born in Asia, the Pacific Islands, Africa, and
other regions with high or intermediate
endemicity of HBV infection should be tested
for HBsAg, regardless of vaccination status.
Initiating HepB
vaccination of immigrant children should not
be delayed while awaiting HBsAg test results:
you may draw blood for testing then administer
the first dose of
vaccine at the same visit. All people found to
be HBsAg-positive should have ongoing medical management by a physician knowledgeable about
hepatitis B
and its complications. |
|
|
|
|
|
| Which
hepatitis B vaccines can be given to adult
patients? |
|
| Twinrix
(combination HepA-HepB, 3-dose series) and
Heplisav-B (2-dose series) are approved for
adults age 18 years and older. Engerix-B and
Recombivax HB (as a 1.0 mL 3-dose series) are
approved for adults age 20 years and older. |
|
| Which adults
should receive HepB vaccine? |
|
| The following
groups are recommended for hepatitis B
vaccination: |
|
| • |
|
Sex partners of HBsAg-positive people |
|
|
|
| • |
|
Sexually active people who are not in
long-term, mutually monogamous
relationships |
|
|
|
| • |
|
People seeking evaluation or treatment
for a sexually-transmitted infection |
|
|
|
| • |
|
Men who
have sex with men |
|
|
|
| • |
|
Current or
recent injection drug users |
|
|
|
| • |
|
Household
contacts of HBsAg-positive people |
|
|
|
| • |
|
Residents
and staff of facilities for
developmentally disabled people |
|
|
|
| • |
|
Healthcare
and public safety workers with
reasonably anticipated risk for exposure
to blood or blood-contaminated body
fluids |
|
|
|
| • |
|
People with end-stage renal disease,
including predialysis, hemo-,
peritoneal-, and home-dialysis patients |
|
|
|
| • |
|
International travelers to regions with
intermediate or high levels of HBV
infection; visit
wwwnc.cdc.gov/travel/yellowbook/2020/travel-related-infectious-diseases/hepatitis-b for
countries with intermediate or high
levels of HBV infection |
|
|
|
| • |
|
People with
chronic liver disease, including, but
not limited to, persons with cirrhosis,
fatty liver disease, alcoholic liver
disease, autoimmune
hepatitis, and an alanine
aminotransferase (ALT) or aspartate
aminotransferase (AST) level greater
than twice the upper limit of normal |
|
|
|
| • |
|
People with
hepatitis C virus infection |
|
|
|
| • |
|
People with HIV infection |
|
|
|
| • |
|
Unvaccinated adults with diabetes
mellitus from 19 through 59 years of age |
|
|
|
| • |
|
Unvaccinated adults with diabetes
mellitus who are age 60 or older at the
clinician's discretion |
|
|
|
| • |
|
Incarcerated persons |
|
|
|
| • |
|
All other
people who wish to be protected from HBV
infection |
|
|
| Acknowledgement
of a specific risk factor is NOT a requirement
for vaccination. The official CDC recommendations for HepB vaccination of are
available
at
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf. |
| |
| Please provide
details about the ACIP recommendation for the
use of hepatitis B vaccine in adult diabetic patients. |
|
| In 2011, CDC
published ACIP recommendations that HepB
vaccine be given to adults with diabetes. The
HepB series is recommended for unvaccinated
adults with diabetes age 59 years and younger.
Among people in this age group with no other
risk factors for hepatitis B, studies have
shown that adults
with diabetes have twice the odds of
developing acute hepatitis B compared to those
without diabetes. Among older age groups the
increased risk was not
as high but at the discretion of the treating
clinician, the vaccine also may be
administered to unvaccinated adults with
diabetes age 60 years and older.
There have been a number of outbreaks of HBV infection in settings that provide assisted
blood glucose monitoring for people with
diabetes. |
|
| Administration of
either the 2-dose (Heplisav-B) or 3-dose (Engerix-B,
Recombivax) HepB series should be completed as
soon as feasible after diabetes is
diagnosed. No serologic testing or additional
HepB vaccination is recommended for adults who
received a complete series of HepB
vaccinations at any
time in the past. |
|
| HepB vaccine may
be administered during healthcare visits
scheduled for other purposes, as long as
minimum intervals between doses are observed.
No
maximum interval between doses exists that
would make the HepB vaccination series
ineffective or that would require restarting
the series. You can read
the details of this recommendation and the
rationale behind it in the December 23, 2011
issue of MMWR, available at
www.cdc.gov/mmwr/pdf/wk/mm6050.pdf,
pages 1709-1711. |
|
| Does the
recommendation to administer hepatitis B
vaccine to diabetics younger than age 60
extend to women with gestational diabetes? |
|
| No. The 2011 CDC
recommendations for HepB vaccination of people
with diabetes pertain to those with type-1 and type-2 diabetes. They do not apply to
women with gestational diabetes. It is worth
noting that pregnancy is not a contraindication to HepB vaccination, and that
women with gestational diabetes
are more likely to develop type-1 or type-2
diabetes later in life. Diabetic women who
become pregnant can be vaccinated, if
indicated. |
|
| At what
anatomic site should hepatitis B vaccine be
administered to adults? What needle size
should be used? |
|
| The deltoid
muscle is recommended for routine
intramuscular (IM) vaccination among adults.
The anterolateral thigh also can be used. The
gluteus muscle
should not be used as a site for administering
HepB. Please refer to the IAC document
Administering Vaccines to Adults: Dose, Route,
Site, and Needle
Size (available at
www.immunize.org/catg.d/p3084.pdf)
for complete information on this issue. |
| |
| Is
post-vaccination testing needed for adults who
receive hepatitis B vaccine? |
|
| Serologic testing
for immunity after HepB vaccination is
recommended only for people whose subsequent
clinical management depends on knowledge of
their immune status. Testing is not necessary
after routine vaccination of adults. |
|
| Post-vaccination
anti-HBs testing is recommended for the
following: healthcare and public safety
workers at a reasonable risk of continued
exposure to
blood on the job; immune compromised people;
and sex or needle-sharing partners of HBsAg-positive
people. Testing should be performed 1 to 2
months
after the last dose of vaccine. |
|
| If a person
has been sexually assaulted, should he/she be
offered HBIG and hepatitis B vaccine? |
|
| Sexually
transmitted infections, including hepatitis B,
can be transmitted by sexual assault. Unless
the victim has a documented history of
completed HepB
vaccination, a series of HepB alone (2 or 3
doses depending on brand) should be
administered with the first dose as soon as
possible after the assault.
Administration of hepatitis B immune globulin
(HBIG) is not necessary. |
|
| If a patient
receives HepB vaccine while undergoing
hemodialysis, will the vaccine be effective?
Will the dose need to be repeated? |
|
| Neither the
Advisory Committee on Immunization Practices
(ACIP) nor the manufacturers address the
timing of vaccination and dialysis. Persons
with
end-stage renal disease including predialysis,
hemodialysis, peritoneal dialysis, and home
dialysis should be tested for hepatitis B
surface antibody (anti-HBs) 1–2 months after vaccination, and
annually. If the anti-HBs level is below
10mIU/mL, they should be revaccinated. |
|
| How often do
hemodialysis patients who have received HepB
vaccination have to be tested for anti-HBs and
HBsAg? |
|
| Recommendations
for immune compromised people, such as
hemodialysis patients, are different than
those for immune-competent people.
Hemodialysis
patients who do not respond to an initial
vaccine series should be revaccinated with two
to four additional doses of HepB (depending on
the brand).
Hemodialysis patients are considered immune as
long as they have adequate anti-HBs (at least
10 mIU/mL). For hemodialysis patients who have
responded with adequate anti-HBs (postvaccination
testing should be done 1 to 2 months after the
vaccine series) to HepB vaccination, no HBsAg
testing
is needed but anti-HBs should be done
annually. If anti-HBs declines below 10 mIU/mL,
a booster dose of HepB should be given and
annual anti-HBs
testing should be continued. Retesting
immediately after the booster dose is not
necessary. |
|
| What is the
maximum number of hepatitis B vaccine doses a
dialysis patient can receive? |
|
| There is no
maximum number of HepB booster doses a
dialysis patient can receive. Serology should
be performed once a year and a booster dose
given
if serology is negative (less than 10 mIU/mL).
Serology is not recommended more frequently
than once a year, so boosters wouldn't be
given more than
once a year. |
|
| A physician
ordered a 40-mcg dose of hepatitis B vaccine
for a hemodialysis patient. The clinic does
not stock the Recombivax HB 40-mcg dose
dialysis
formulation (Merck) and would like to give 2
doses of Engerix-B 20-mcg dose (GSK) for each
dose in the series. Is this acceptable? |
|
| Yes. If given on
the same day as separate injections in
separate sites, two injections of Engerix-B 20
mcg can be counted as the equivalent of one
Recombivax HB 40-mcg dose. According to the
package insert, Engerix-B is licensed for use
in this manner (vaccine package inserts for
all vaccines are
available at
www.immunize.org/fda). Note that
an all-Engerix-B or mixed-brand dialysis
schedule is a 4-dose series (doses at 0, 1, 2,
and 6 months).
Vaccination using only Recombivax HB dialysis
formulation is a 3-dose schedule (doses at 0,
1, and 6 months). Vaccination of a
hemodialysis patient also
may be completed with Heplisav-B using the
standard 0.5 mL dose in a 2-dose series (1
month apart). |
|
| Some
nephrologists give a high dose (40 mcg) of
hepatitis B vaccine (2 adult doses of Engerix-B,
or Recombivax HB Dialysis Formulation) to all
patients
with renal failure with glomerular filtration
rates (GFRs) of less than 30 ml/min even if
the patient is not on dialysis. Is this
practice advisable? |
|
| When using
Engerix-B or Recombivax HB brands of HepB to
vaccinate hemodialysis or other immunocompromised people, a higher dose is
recommended, so to the extent these patients
are immunocompromised, this is within ACIP
recommendations (note that "immunocompromised"
is not
defined in the recommendations). Regardless,
this practice is appropriate for several
reasons, including that these patients may be
starting hemodialysis
soon, and because use of the higher dose is
not harmful. This is somewhat of a gray area but the clinician can use his/her clinical
judgment. When using
Heplisav-B, the standard 0.5 mL dose in a
2-dose series (1 month apart) is recommended. |
|
| Can a dialysis
or pre-dialysis patient receive Heplisav-B
vaccine? |
|
| Yes. Use the
standard dose and dosing interval (1 month). |
|
| I would like
more information about Twinrix, the
combination hepatitis A and B vaccine. |
|
| Twinrix
(GlaxoSmithKline) is an inactivated
combination vaccine containing both hepatitis
A virus (HAV) and HBV antigens. The vaccine
contains 720 EL.U.
of hepatitis A antigen (half of the Havrix
adult dose) and 20 mcg of hepatitis B antigen
(the full Engerix-B adult dose). In the United
States, Twinrix is
licensed for use in people who are age 18
years or older. It can be administered to
people who are at risk for both hepatitis A
and hepatitis B, such as
certain international travelers, people with
chronic liver disease, men who have sex with
men, illegal drug users, or to people who want
to be immune to
both diseases. |
|
| A standard
Twinrix series consists of 3 doses given
intramuscularly on a 0, 1, and 6 month
schedule. |
|
| In March 2007,
the FDA also approved a 4-dose schedule for
Twinrix. It consists of 3 doses given within 3
weeks, followed by a booster dose at 12 months
(0, 7 days, 21 to 30 days, and 12 months). The
4-dose schedule could benefit individuals
needing rapid protection from hepatitis A and
hepatitis B, such
as some people traveling imminently. |
|
| Twinrix cannot be
used for post-exposure prophylaxis. |
|
| I have seen
adults who have had 1 or 2 doses of Twinrix,
but we only carry single-antigen vaccine in
our practice. How should we complete their
vaccination series with single-antigen
vaccines? |
|
| Twinrix is
licensed as a 3-dose series for people age 18
years and older. If Twinrix is not available
or if you choose not to use Twinrix to
complete the
hepatitis A vaccine (HepA) and HepB series,
you should do the following: |
|
| • |
|
If 1 dose of Twinrix was given, complete
the series with 2 adult doses of HepA
and 2 adult doses of HepB. |
|
|
|
| • |
|
If 2 doses of Twinrix were given,
complete the schedule with 1 adult dose
of HepA and 1 adult dose of HepB. |
|
|
| Another way to
consider this is as follows: |
|
| • |
|
A dose of Twinrix contains a standard
adult dose of HepB and a pediatric dose
of HepA. So a dose of Twinrix can be
substituted for any dose of
the HepB series but not for any dose of
the HepA series. |
|
|
|
| • |
|
Any combination of 3 doses of adult HepB
or 3 doses of Twinrix is a complete
series of HepB |
|
|
|
| • |
|
One dose of
Twinrix and 2 doses of adult HepA is a
complete series of HepA |
|
|
|
| • |
|
Two doses
of Twinrix and 1 dose of adult HepA is a
complete series of HepA |
|
|
| We're thinking
of using Twinrix and we're wondering whether
we can use it for doses #1 and #3 only and use
single antigen hepatitis B vaccine for dose
#2? |
|
| No. Twinrix
contains 50% less hepatitis A antigen
component than Havrix, GSK's monovalent HepA
[720 vs. 1440 El. U.], so the patient would
not receive
the recommended dose of HepA antigen. |
|
| What are the
minimum intervals for giving the 3-dose series
of Twinrix? |
|
| Minimum intervals
for Twinrix are 4 weeks between dose #1 and
dose #2, and 5 months between dose #2 and dose
#3. |
|
|
|
|
|
| Which people
who work in healthcare settings need hepatitis
B vaccine? |
|
| The Occupational
Safety and Health Administration (OSHA)
requires that HepB be offered to healthcare
personnel (HCP) who have a reasonable
expectation of being exposed to blood and body
fluids on the job. This requirement does not
include personnel who would not be expected to
have
occupational risk (for example, general office workers). Employers must ensure that workers
who decline HepB vaccination sign a
declination form. For a
fact sheet about this OSHA requirement, go to:
www.osha.gov/OshDoc/data_BloodborneFacts/bbfact05.pdf. |
|
| At what
anatomic site should hepatitis B vaccine be
administered to adults? What needle size
should be used? |
|
| For adults,
administer HepB intramuscularly (IM) in the
deltoid muscle. A 22- to 25-gauge, 1–1½ -inch
needle should be used. The gluteus muscle
should
not be used as a sit for administering HepB.
For optimal protection, it is crucial that the
vaccine be administered IM, not
subcutaneously. |
|
| Can Heplisav-B
be used for vaccinating healthcare
professionals? |
|
| Yes. Heplisav-B
is approved as a 2-dose schedule for persons
age 18 years and older, including healthcare professionals. The doses should be separated
by at least 4 weeks. |
|
| Can Heplisav-B
be used to complete a vaccination series
started with Engerix-B or Recombivax HB? |
|
| Yes. However,
data are limited on the safety and
immunogenicity effects when Heplisav-B is
interchanged with HepB from other
manufacturers. When
feasible, the same manufacturer's vaccines
should be used to complete the series.
However, vaccination should not be deferred
when the manufacturer of
the previously administered vaccine is unknown
or when the vaccine from the same manufacturer
is unavailable. |
|
| The 2-dose HepB
series only applies when both doses in the
series consist of Heplisav-B. Series
consisting of a combination of 1 dose of Heplisav-B and
a vaccine from a different manufacturer should
consist of 3 total vaccine doses and should
adhere to the 3-dose schedule minimum
intervals of 4 weeks
between dose 1 and 2, 8 weeks between dose 2
and 3, and 16 weeks between dose 1 and 3.
Doses administered at less than the minimum
interval should
be repeated. However, any series containing 2
doses of Heplisav-B administered at least 4
weeks apart is valid, even if the patient
received a single earlier
dose from another manufacturer. |
|
| I work in
occupational health and have some patients who
are off schedule for their 3-dose hepatitis B vaccine series. They came back for dose #2 in
4 to
6 months rather than getting it 1 month later.
In this situation, what is the correct timing
for dose #3? And how long must the interval be
between doses
before I am required to restart the series? |
|
| The minimal
intervals for the 3-dose HepB vaccines are at
least 4 weeks between doses #1 and #2, at
least 8 weeks between doses #2 and #3, and at
least
16 weeks between doses #1 and #3. Since in
your cases 16 weeks or more have elapsed since
dose #1, you should schedule dose #3 to be
given 8
weeks after dose #2. It is not necessary to restart the series because of an extended
interval between doses, no matter how long. |
|
| Is it safe for
a healthcare professional to be vaccinated
during pregnancy? |
|
| Yes. Many years
of experience with HepB vaccines indicate no
apparent risk for adverse events to a
developing fetus. Current HepB vaccines
contain
noninfectious hepatitis B surface antigen (HBsAg)
and should pose no risk to the fetus. If not
vaccinated, a pregnant woman may contract an
HBV
infection during pregnancy, which might result in severe disease for the newborn. Women who
breastfeed their babies and are healthcare
professionals
can and should be vaccinated against hepatitis
B if they haven't been previously vaccinated.
Receipt of the vaccine is not a reason to
discontinue
breastfeeding. |
|
| There are no
clinical studies of Heplisav-B in pregnant
women. Available human data on Heplisav-B
administered to pregnant women are
insufficient to
assess vaccine-associated risks in pregnancy.
Until safety data are available for Heplisav-B,
providers should continue to vaccinate
pregnant women
needing HepB vaccination with a vaccine from a
different manufacturer. |
|
| Which HCP need
serologic testing after receiving a hepatitis
B vaccine series? |
|
| All HCP,
including trainees, who have a high risk of
occupational percutaneous or mucosal exposure
to blood or body fluids (for example, HCP with
direct
patient contact, HCP at risk of needlestick or
sharps injury, laboratory workers who draw,
test or handle blood specimens) should have postvaccination
testing for antibody to hepatitis B surface
antigen (anti-HBs). Postvaccination testing
should be done 1–2 months after the last dose
of vaccine.
Postvaccination testing for persons at low
risk for mucosal or percutaneous exposure to
blood or body fluids (for example, public
safety workers and HCP
without direct patient contact) likely is not
cost-effective; however, those who do not
undergo postvaccination testing should be
counseled to seek
immediate testing if exposed. |
|
| What should be
done if a healthcare personnel's
postvaccination anti-HBs test is negative
(less than 10 mIU/mL) 1–2 months after the
last dose of
vaccine? |
|
| There are two
options for healthcare personnel who test
negative after completing their first HepB
series. The first option is to give one dose
of HepB, then
retest for anti-HBs. If the result is
positive, the person should be considered
immune. If negative, the person should receive
the remaining doses in the
series, and then retest for anti-HBs. If the
result is positive, the person should be
considered immune. If negative, the person
should be tested for HBsAg
and total anti-HBc to determine their HBV
infection status. People who test negative for
HBsAg and total anti-HBc should be considered
vaccine non-responders and susceptible to HBV infection.
They should be counseled about precautions to
prevent HBV infection and the need to obtain
hepatitis B
immune globulin (HBIG) prophylaxis for any
known or likely exposure to HBsAg-positive
blood. Those found to be HBsAg negative but
total anti-HBc
positive were infected in the past and require
no vaccination or treatment. If the HBsAg and
total anti-HBc tests are positive, the person
should receive
appropriate counseling for preventing
transmission to others as well as referral for
ongoing care to a specialist experienced in
the medical management of
chronic HBV infection. They should not be
excluded from work. |
|
| The second option
is to repeat the 2- or 3-dose series
(depending on vaccine brand) and test for
anti-HBs 1–2 months after the final dose of
the repeat
series. Heplisav-B may be used for
revaccination following an initial HepB series
that consisted of doses of Heplisav-B or doses
from a different
manufacturer. Heplisav-B may also be used to revaccinate new healthcare personnel
(including the challenge dose) initially
vaccinated with a vaccine from
a different manufacturer in the distant past
who have anti-HBs less than 10 mIU/mL upon
hire or matriculation. |
|
| If the test is
still negative after a second vaccine series,
the person should be tested for HBsAg and
total anti-HBc to determine their HBV
infection status.
People who test negative for HBsAg and total
anti-HBc should be considered vaccine
non-responders and susceptible to HBV
infection. They should be
counseled about precautions to prevent HBV
infection and the need to obtain hepatitis B
immune globulin (HBIG) prophylaxis for any
known or likely
exposure to HBsAg-positive blood. Those found
to be HBsAg negative but total anti-HBc
positive were infected in the past and require
no vaccination or
treatment. If the HBsAg and total anti-HBc
tests are positive, the person should receive
appropriate counseling for preventing
transmission to others as well
as referral for ongoing care to a specialist
experienced in the medical management of
chronic HBV infection. They should not be
excluded from work. |
|
| The choice of
option 1 and option 2 should be based on
epidemiologic considerations and likelihood
that the patient is HBsAg positive, since
there is a
delay in option 1 in determining HBsAg status. |
|
| How often
should I test HCP after they've received the
hepatitis B vaccine series to make sure
they're protected? |
|
| For
immunocompetent HCP, periodic testing or
periodic boosting is not needed.
Postvaccination testing (anti-HBs) should be
done 1–2 months after the
last dose of the HepB series. If adequate
anti-HBs (at least 10 mIU/mL) is present,
nothing more needs to be done. This
information should be made
available to the employee and recorded in the
employee's health record. If postvaccination
testing is less than 10 mIU/mL, follow the
steps for option 1 or
option 2 as detailed in the previous question. |
|
| Should a
healthcare professional who performs invasive
procedures and who once had a positive anti-HBs
result be revaccinated if the anti-HBs titer
is
rechecked and is less than 10 mIU/mL? |
|
| No.
Immunocompetent people known to have responded
to HepB vaccination in the past do not require
additional passive or active immunization.
Postvaccination testing should be done 1–2
months after the original vaccine series is
completed. In this scenario, the initial postvaccination testing
showed that the healthcare professional was protected. Substantial evidence suggests that
adults who respond to a HepB series (anti-HBs
of at least 10
mIU/mL) are protected from chronic HBV
infection for at least 30 years, even if there
is no detectable anti-HBs currently. Only
immunocompromised
people (for example, dialysis patients, some
people living with HIV) need to have anti-HBs
testing performed periodically. Booster doses
of vaccine to
maintain their protective anti-HBs
concentrations to at least 10 mIU/mL are
recommended for dialysis patients and may be
given to some people living with
HIV. |
|
| Table 3: Postexposure management of healthcare
personnel after occupational percutaneous and
mucosal exposure to blood and body fluids, by
healthcare personnel HepB vaccination and
response status |
|
|
Healthcare personnel status |
Postexposure testing |
Postexposure prophylaxis |
Postvaccination
serologic
testing† |
Source
patient
(HBsAg) |
HCP
testing
(anti-HBs) |
HBIG* |
Vaccination |
Documented responder§ after
complete series |
No action needed |
Documented
nonresponder¶
after 2 complete series |
Positive/unknown |
Not indicated |
HBIG x2 separated
by 1 month |
— |
No |
|
Negative |
No action needed |
Response
unknown after
complete series |
Positive/unknown |
<10mIU/mL** |
HBIG x1 |
Initiate
revaccination |
Yes |
|
Negative |
<10mIU/mL |
None |
|
Any result |
>10mIU/mL |
No action needed |
Unvaccinated/incompletely
vaccinated or vaccine refusers |
Positive/unknown |
—** |
HBIG x1 |
Complete
vaccination |
Yes |
|
Negative |
— |
None |
Complete
vaccination |
Yes |
|
|
Abbreviations: HCP = health-care
personnel; HBsAg = hepatitis B surface
antigen; anti-HBs = antibody to
hepatitis B surface antigen; HBIG =
hepatitis B
immune globulin. |
|
* |
HBIG should be administered
intramuscularly as soon as possible
after exposure when indicated. The
effectiveness of HBIG when
administered >7 days after percutaneous, mucosal, or nonintact
skin exposures is unknown. HBIG dosage
is 0.06 mL/kg. |
| † |
Should be
performed 1–2 months after the last
dose of the HepB vaccine series (and
6 months after administration of HBIG to avoid detection of passively
administered anti-HBs) using a
quantitative method that allows
detection of the protective
concentration of anti-HBs (>10
mIU/mL). |
| § |
A
responder is defined as a person with
anti-HBs >10 mIU/mL after 1
or more complete series of HepB vaccine. |
|
¶ |
A
nonresponder is defined as a person
with anti-HBs <10 mIU/mL after 2
complete series of HepB vaccine. |
|
** |
HCP who
have anti-HBs <10mIU/mL, or who are
unvaccinated or incompletely
vaccinated, and sustain an exposure to
a source patient who is HBsAg-positive
or
has unknown HBsAg status, should
undergo baseline testing for HBV
infection as soon as possible after
exposure, and follow-up testing
approximately 6 months
later. Initial baseline tests consist
of total anti-HBc; testing at
approximately 6 months consists of
HBsAg and total anti-HBc. |
|
|
Source: This table
from Prevention of Hepatitis B Virus
Infection in the United States:
Recommendations of the Advisory
Committee on Immunization Practices.
MMWR 2018;67(RR-1): 18
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.pdf |
|
|
| Does CDC
recommend routine pre-exposure anti-HBs
testing of all healthcare personnel who were previously vaccinated? |
|
| In general, no,
but the type of testing (pre-exposure or
post-exposure) depends on the healthcare
worker's profession and work setting. The risk
for
hepatitis B virus (HBV) infection for
vaccinated healthcare personnel (HCP) can vary
widely by setting and profession. The risk
might be low enough in
certain settings that assessment of hepatitis
B surface antibody (anti-HBs) status and
appropriate follow-up can be done at the time
of exposure to
potentially infectious blood or body fluids.
This approach relies on HCP recognizing and
reporting blood and body fluid exposures and
might be applied on
the basis of documented low risk,
implementation, and cost considerations.
Trainees, some occupations (such as those with
frequent exposure to sharp
instruments and blood), and HCP practicing in
certain populations are at greater risk of
exposure to blood or body fluid exposure from
an HBsAg-positive
patient. Vaccinated HCP in these
settings/occupations would benefit from a
pre-exposure approach. |
|
| We have a new
employee with documentation of having received
a series of hepatitis B vaccine as an adolescent. He now tests negative for
hepatitis B
surface antibody (anti-HBs). How should we
manage him? |
|
|
ACIP recommends that
healthcare personnel with written
documentation of having received a properly
spaced series of HepB in the past (such as in
infancy or adolescence) but who now test
negative for anti-HBs should receive a single
"booster" or "challenge" dose of HepB and be
retested 1–2 months
later. Those who test positive following the
"booster" dose are immune and require no
further vaccination or testing. Those who test
negative should
complete a second 2- or 3-dose series of HepB
on the usual schedule and be tested again 1–2
months after the last dose. The "booster" dose
counts as
the first dose in this series. Heplisav-B may
be used to revaccinate new healthcare
personnel (including the challenge dose)
initially vaccinated with a
vaccine from a different manufacturer in the
distant past who have anti-HBs less than 10
mIU/mL upon hire or matriculation. For more information see
www.cdc.gov/mmwr/volumes/67/rr/pdfs/rr6701-H.PDF,
pages 21–22. |
| |
| If an employee
receives both HBIG and hepatitis B vaccine
after a needlestick from a patient who is
HBsAg positive, how long should one wait to
check the
employee's response to the vaccine? |
|
| Anti-HBs testing
for HCP who receive both hepatitis B immune
globulin (HBIG) and hepatitis B vaccine can be conducted as soon as 6 months after
receipt of the HBIG. |
|
|
At our facility we
do routine pre-employment anti-HBs testing
regardless of whether the employee has documentation of a hepatitis B vaccination
series
and consider those who are anti-HBs positive
to be immune. Is this the recommended
strategy? |
|
| No. HCP with
written documentation of receipt of a
complete, properly spaced HepB series AND a
positive anti-HBs can be considered immune to
HBV
and require no further testing or vaccination.
Testing unvaccinated or incompletely
vaccinated HCP (including those without
written documentation of
vaccination) is not necessary and is
potentially misleading because anti-HBs of 10
mIU/mL or higher as a correlate of
vaccine-induced protection has only
been determined for persons who have completed
a HepB vaccination series. Persons who cannot
provide written documentation of a complete
HepB
vaccination series should complete the series,
then be tested for anti-HBs 1 to 2 months
after the final dose. |
|
|
Is there a
recommendation for a routine booster dose of
hepatitis B vaccine? |
|
| No. HCP who have
documentation of receiving a complete HepB
series and who tested positive for anti-HBs
(defined as anti-HBs of 10 mIU/mL or higher)
are considered to be immune to hepatitis B.
Immunocompetent persons have long-term
protection against HBV and do not need further
testing or vaccine
doses. Some immunodeficient persons (including
those on hemodialysis) may need periodic
booster doses of hepatitis B vaccine. |
|
|
Does CDC recommend
restarting the hepatitis B vaccine series in
the event the series is interrupted? |
|
| No. The series
should not be restarted. Continue the series
from where you left off. |
|
| Several
physicians in our group have no documentation
showing they received hepatitis B vaccine.
They are relatively sure, however, that they
received
the doses many years ago. What do we do now? |
|
| Because there is
no documentation of vaccination, a vaccination
series should be administered and postvaccination testing should be performed
1–2
months after the final dose of vaccine. There
is no harm in receiving extra doses of
vaccine. Postvaccination anti-HBs testing
results should also be
documented, including the date testing was
performed. All healthcare settings should
develop policies or guidelines to assure valid hepatitis B
immunization. |
|
|
An employee thinks she had 3 doses of
hepatitis B vaccine in the past but has no
documentation of receiving those doses. Before
reading the
recommendations to revaccinate her, we
obtained an anti-HBs titer and the result was
greater than 10 mIU/mL. With this lab result,
can't we assume she is
immune? |
|
| No. A positive
anti-HBs indicates that the vaccinated person
is immune at the time the person was tested
but does not assure that the person has
long-term
immunity. Long-term immunity has been
demonstrated only for people attaining an
adequate anti-HBs result of at least 10 mIU/mL
after completing a full
vaccination series. The most direct way to
deal with this is to vaccinate the employee
with a series of hepatitis B vaccine; test for
anti-HBs in 1–2 months
and document the result in the employee's
health record. An adequate anti-HBs result
from a documented vaccine series would assure
not only
seroprotection, but long-term protection. |
|
|
I'm a nurse who
received the hepatitis B vaccine series more
than 10 years ago and had a positive follow-up
titer (at least 10 mIU/mL). At present, my
titer
is negative (less than 10 mIU/ mL). What
should I do now? |
|
|
Do nothing. Data show that vaccine-induced
anti-HBs levels might decline over time;
however, immune memory (anamnestic anti-HBs
response) remains
intact following immunization. People with
anti-HBs concentrations that decline to less
than 10 mIU/mL are still protected against HBV
infection. For HCP
with normal immune status who have
demonstrated adequate anti-HBs (at least 10
mIU/ mL) following full vaccination, booster
doses of vaccine or periodic
anti-HBs testing are not recommended. |
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If an employee
does not respond to hepatitis B vaccination
(employee has had two full HepB series), does s/he need to be removed from activities that
expose her/him to bloodborne pathogens? Does
the employer have a responsibility in this
area beyond providing vaccine? |
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|
No. There are no regulations that require
removal from job situations where exposure to
bloodborne pathogens could occur; this is an
individual policy
decision within the organization. OSHA
regulations require that employees in jobs
where there is a reasonable risk of exposure
to blood be offered
hepatitis B vaccine. In addition, the regulation states that adequate personal
protective equipment be provided and that
standard precautions be followed.
Check your state OSHA regulations regarding
additional requirements. If there are no state
OSHA regulations, federal OSHA regulations
should be
followed. Adequate documentation should be
placed in the employee record regarding
non-response to vaccination. HCP who do not
respond to
vaccination should be tested for HBsAg and
total anti-HBc to determine if they have
chronic HBV infection. If the HBsAg and total
anti-HBc tests are
positive, HCP should receive appropriate
counseling for preventing transmission to
others as well as referral for ongoing care to
a specialist experienced
in the medical management of chronic HBV
infection. Persons who are HBsAg-positive and
who perform exposure-prone procedures should
seek counsel
from a review panel comprised of experts with
a balanced perspective (for example,
infectious disease specialists and their
personal physician[s])
regarding the procedures that they can perform
safely. They should not be excluded from work. People who test negative for HBsAg should be
considered
susceptible to HBV infection and should be
counseled about precautions to prevent HBV
infection and the need to obtain HBIG
prophylaxis for any known
or likely exposure to HBsAg-positive blood
(see Table 3). |
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|
Can a person with
chronic HBV infection work in a healthcare
setting? |
|
| Yes. HCP should
not be discriminated against because of their
hepatitis B status. All HCP should practice
standard precautions, which are designed to
prevent HBV transmission, both from patients
to HCP and from HCP to patient. There is,
however, one caveat concerning HBV-infected HCP. Those who
have HBV levels 1000 IU/mL or 5000 genomic
equivalents/mL or higher should not perform
exposure-prone procedures (for example,
gynecologic,
cardiothoracic surgery) unless they have
sought counsel from an expert review panel and
been advised under what circumstances, if any,
they may
continue to perform these procedures. For more
information on this issue, see "Updated CDC
Recommendations for the Management of
Hepatitis B
Virus–Infected Health-Care Providers and Students," MMWR, 2012; 61(RR03):1–12. This
document is available at
www.cdc.gov/mmwr/pdf/rr/rr6103.pdf. |
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|
|
| Is hepatitis B
vaccine safe? |
|
| Yes. Hepatitis B
vaccines have been demonstrated to be safe
when administered to infants, children,
adolescents, and adults. Since 1982, more than
100
million people, including infants, children,
and adults living in the United States have
received at least one dose of hepatitis B
vaccine; more than a billion
doses of hepatitis B vaccine have been given
worldwide. Vaccination causes a sore arm
occasionally, but serious reactions are very
rare. |
|
| Is it safe to
give hepatitis B vaccine to a pregnant woman? |
|
| Yes. Many years
of experience with HepB vaccines indicates no
apparent risk for adverse events to a
developing fetus. Current vaccines contain
noninfectious HBsAg and pose no risk to the
fetus. If the mother is being vaccinated because she is at risk for HBV infection (for
example, a healthcare
worker, a person with a sexually transmitted disease, an injection drug user, a person with
multiple sex partners, or a person with
diabetes who is 19
through 59 years of age), vaccination should
be initiated as soon as her risk factor is
identified during the pregnancy. HBV infection
affecting a pregnant
woman might result in severe disease for the
mother and chronic infection for the newborn. |
|
| There are no
clinical studies of Heplisav-B in pregnant
women. Available human data on Heplisav-B
administered to pregnant women are
insufficient to
assess vaccine-associated risks in pregnancy.
Until safety data are available for Heplisav-B,
providers should continue to vaccinate
pregnant women
needing hepatitis B vaccination with a vaccine
from a different manufacturer. |
|
| Does a birth
dose of vaccine increase the risk of elevated
temperature and subsequent microbiologic evaluations? |
|
| No.
Administration of HepB soon after birth has
not been associated with an increased rate of
elevated temperatures or subsequent
evaluations for
possible sepsis in the first 21 days of life. |
|
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|
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|
| Who should not
receive hepatitis B vaccine? |
|
| A serious
allergic reaction to a prior dose of hepatitis
B vaccine or a vaccine component is a
contraindication to further doses of HepB
vaccine. The
recombinant vaccines that are licensed for use
in the United States are synthesized in yeast
cells into which a plasmid containing the gene
for HBsAg has
been inserted. Purified HBsAg is obtained by lysing the yeast cells and separating HBsAg
from the yeast components by biochemical and biophysical
techniques. People with a severe allergic to
yeast should not be vaccinated with vaccines
produced in yeast cells. |
|
| As with other
vaccines, vaccination of people with moderate
or severe acute illness, with or without
fever, should be deferred until the illness
improves.
Vaccination is not contraindicated in people
with a history of multiple sclerosis,
Guillain-Barré syndrome, or autoimmune
diseases such as systemic lupus erythematosis or rheumatoid arthritis. |
|
| Vaccine Storage and Handling |
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| How should
hepatitis B vaccine be stored? |
|
| All hepatitis
B-containing vaccines should be stored at
refrigerator temperature at 2°C to 8°C (35°F
to 46°F). The vaccines must not be frozen. Any
vaccine exposed to freezing temperature should
not be used. Do not use these or any other
vaccines after the expiration date shown on
the packaging.
Any vaccine administered after its expiration date should be repeated. |
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ACIP Recommendations
Vaccine Information Statements 
