|
|
|
|
|
| What are the signs and symptoms
of hepatitis B? |
 |
| About 7 out of 10 adults with
acute hepatitis B have signs or symptoms when infected
with HBV. Children under age 5 years who become infected
rarely show any symptoms. Signs and symptoms of hepatitis
B might include nausea, lack of appetite, tiredness, muscle,
joint, or stomach pain, fever, diarrhea or vomiting, headache,
dark urine, light-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. The case fatality rate among
persons with reported cases of acute hepatitis B is
approximately 1.5%, with the highest rates occurring in adults
who are over 60 years of age. |
|
| How long does it take to
show signs of illness after a person becomes infected
with hepatitis B virus (HBV)? |
|
| The incubation period ranges
from 45 to 160 days (average 120). |
|
| Can HBV be transmitted
in daycare via saliva, e.g., drooling infants? |
|
| Though HBV has
been found in saliva, there are no data to suggest that saliva
alone transmits HBV infection. There have been reports of HBV
transmission when an HBV-infected person bites another person.
In these reports, bloody saliva was usually present in the
infected person's mouth and the blood was more likely the
vehicle of transmission. HBV is not spread by kissing,
hugging, sneezing, coughing, food or water, sharing eating
utensils or drinking glasses, or casual contact. |
|
| Can HBV be transmitted by sharing cups or straws? |
|
| There are no data to suggest
that sharing drinking cups, straws, or other eating utensils,
have been associated with HBV transmission. |
|
| More of my patients
are getting tattoos and body piercings. Should they be
concerned about contracting a bloodborne infection like
HBV? |
|
| Yes. 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.
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.
Persons 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.
IAC
has created a website with links to relevant articles
from medical journals and publications from national sources
such as CDC, HCV Advocate, the Alliance of Professional
Tattooists, and the Association of Professional Piercers.
Feel free to refer patients who are considering one or
both of these forms of body art to www.immunize.org/tattoos. |
|
| What is the risk for
transmitting HBV by oral sex? |
|
| 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. |
|
| Can "French" kissing transmit
HBV? |
|
| While HBV has been found in
saliva, there are no data to suggest that kissing transmits
HBV; however, there have not been studies to specifically
look at "French" kissing. |
|
| 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 sex partner (I don't have one
now) should wait after taking this vaccine, before having
sex with me without any risk of transmission. |
|
| You should use
condoms (the efficacy of latex condoms in preventing infection
with HBV is unknown, but their proper use might reduce
transmission) until a postvaccination blood test (anti-HBs)
shows that your sex partner is protected from HBV infection.
For example, your sexual partner should have the 3-dose
series of hepatitis B vaccine and postvaccination testing
1-2 months after the last dose of vaccine. If your sexual
partner's test shows adequate anti-HBs (at least 10 mIU/mL),
then he/she should be protected against HBV infection. |
|
| If a patient is diagnosed
with acute hepatitis B and then resolves the infection,
can the patient ever get hepatitis B again? |
|
| Generally speaking, no. It
is possible, however, for a person to have two different
HBV infections, the second due to an HBV variant or a different
HBV subtype. |
|
| How stable is HBV in the
environment and what types of equipment cleaners are
viracidal against HBV? |
|
| Any high level
disinfectant that is tuberculocidal will kill HBV. It is important to note that
HBV is quite stable in the environment and remains viable
for 7 or more days on environmental surfaces at room temperature.
The virus is still capable of transmitting HBV despite
the absence of visible blood. |
| |
|
|
|
|
| What are
the various serologic tests for hepatitis B? |
|
| 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 (within the past 6 months). |
| 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. |
| HBV-DNA |
HBV Deoxyribonucleic
acid is a marker of viral replication. It correlates
well with infectivity. It is used to assess and
monitor the treatment of patients with chronic
HBV infection. |
|
|
| How do I
interpret some of the common hepatitis B panel results? |
|
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 |
no
vaccination necessary |
HBsAg
anti-HBc
anti-HBs |
negative
positive
positive |
immune
due to natural 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
recovering from acute HBV infection |
| 2. |
May be
distantly immune, but the test may not be sensitive
enough to detect a very low level of anti-HBs in
serum |
| 3. |
May be
susceptible with a false positive anti-HBc |
| 4. |
May be
chronically infected and have an undetectable level
of HBsAg present in the serum
|
|
|
| My daughter was immunized
against hepatitis B about 4 years ago. She was recently
found "hepatitis B positive" by her gynecologist. Is
this possible? Could it be a false positive? |
|
| It is possible, but unlikely.
The HBsAg test has high sensitivity and specificity and
is quite trustworthy. She might have already been HBsAg
positive when she was vaccinated; therefore, the vaccine
would not have been effective. You should make sure that
the positive test was actually HBsAg and not another hepatitis
B test, such as anti-HBs (sometimes confusingly referred
to as HBsAB) or anti-HBc. A positive anti-HBs test is expected
after vaccination with hepatitis B vaccine, but not a positive
anti-HBc or HBsAg. If you are certain after careful checking
that the test and reported result are correct, you should
then make sure the laboratory that did the test repeated
the test in duplicate and then did neutralization. If your
daughter is ultimately determined to be truly HBsAg positive,
she should be referred to a liver disease specialist for
counseling and medical evaluation. |
|
| 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? |
|
| 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 for reporting inadequate
anti-HBs and 10 or above for reporting adequate anti-HBs.
You should check with your lab to be certain this is being
done. |
| |
|
|
|
|
| Where can I locate CDC's
recommendations for hepatitis B vaccination? |
|
| To obtain "A Comprehensive
Immunization Strategy to Eliminate Transmission of Hepatitis B
Virus Infection in the United States. Recommendations of the
Advisory Committee on Immunization Practices (ACIP). Part 1:
Immunization of Infants, Children and Adolescents," MMWR,
December 23, 2005, Vol. 54(RR-16):1-39 go to www.cdc.gov/mmwr/PDF/rr/rr5416.pdf.
For the adult recommendations titled
"A Comprehensive Immunization Strategy to Eliminate Transmission
of Hepatitis B Virus Infection in the United States. Part II:
Immunization of Adults," MMWR, December 8, 2006;55(RR-16):1-25 go
to www.cdc.gov/mmwr/PDF/rr/rr5516.pdf. |
|
| I understand there is a
now a shortage of HepB vaccine for children and possibly for
adults. Could you please tell me about it and what we should
do to cut back on using it? |
|
| The supply of Merck's
hepatitis B vaccines (pediatric, adult, and dialysis
formulations) is limited at this time, but recommendations for
its use are unchanged. For detailed information about HepB
shortages, go to CDC's website at www.cdc.gov/vaccines/vac-gen/shortages. |
|
| For how long is hepatitis
B vaccine protective? |
|
| Studies indicate that
immunologic memory remains intact for more than 25 years
and confers protection against clinical illness and
chronic HBV infection, even though anti-HBs levels might
become low or decline below detectable levels. |
|
| 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, an estimated
70 million adolescents and adults and 50 million infants
and children in the United States have received at least
one dose of hepatitis B vaccine; a billion doses of hepatitis
B vaccine have been given worldwide. Vaccination causes
a sore arm occasionally, but serious reactions are very
rare. |
|
| Where can I find a
CDC document that states that hepatitis B vaccine doesn't
have to be restarted if the series is interrupted? |
|
| A discussion of interrupted
hepatitis B vaccination schedules can be found in the
recommendations of the ACIP Part 1: Immunization of Infants,
Children, and Adolescents published December 23, 2005. Go to www.cdc.gov/mmwr/PDF/rr/rr5416.pdf. It is on page 8. The
document states: |
|
| • |
|
When the
hepatitis B vaccine schedule is interrupted, the vaccine
series does not need to be restarted. |
| • |
|
If the
series is interrupted after the first dose, the second
dose should be given as soon as possible, and the second
and third doses should be separated by an interval of at
least 8 weeks. |
| • |
|
If only the third dose
is delayed, it should be administered as soon as
possible, after age 24 weeks (164 days). |
| • |
|
It is not necessary to
restart the vaccine series for infants switched from one
vaccine brand to another, including combination
vaccines. |
|
|
| Who should not receive
the vaccine? |
|
A serious allergic reaction
to a prior dose of hepatitis B vaccine or a vaccine component
is a contraindication to further doses of hepatitis B vaccine.
The recombinant vaccines that are licensed for use in the
United States are synthesized by Saccharomyces cerevisiae
(common baker's yeast), 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. Persons allergic to yeast should not be vaccinated
with vaccines containing yeast.
|
Persons with a history of serious
adverse events, including anaphylaxis, after receipt of
hepatitis B vaccine should not receive additional doses.
As with other vaccines, vaccination of persons with moderate
or severe acute illness, with or without fever, should
be deferred until the illness improves. Vaccination is
not contraindicated in persons with a history of multiple
sclerosis, Guillain-Barrè syndrome, or autoimmune
diseases such as systemic lupus erythematosis or rheumatoid arthritis. |
|
| 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 found to occur after
a dose of hepatitis B vaccine. |
|
| How long should a person
wait to donate blood after a dose of hepatitis B vaccine? |
|
| It is advisable to wait one
month. Studies published in the last several years have
found that transient HBsAg positivity (lasting less than
21 days) can be detected in certain persons after vaccination. |
| |
|
|
|
|
| Pregnancy, perinatal, and infant hepatitis B issues |
Back to top |
|
|
|
| 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? |
|
| You can access the
official document
and appendices at: www.cdc.gov/mmwr/PDF/rr/rr5416.pdf. |
|
| What blood test should be used to screen a pregnant woman to prevent perinatal
hepatitis B virus (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 other blood
tests such as total antibody to hepatitis B core antigen
(total anti-HBc) and/or antibody to HBsAg (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 persons and anti-HBs is rarely positive
in an HBsAg-positive person. Women who are found to be
HBsAg positive should then be referred for counseling and
medical evaluation that will include further testing. If
there is reason to suspect recently acquired HBV infection
in a pregnant woman, IgM class anti-HBc (IgM anti-HBc)
could be done to differentiate recently acquired HBV infection
from chronic HBV infection. IgM anti-HBc is the blood test
that is positive in recently acquired HBV infection. |
|
| Our laboratory screens
pregnant women with a hepatitis B panel. Is this correct? |
|
| No. A routine
hepatitis B panel for screening pregnant women is not advised,
nor is it necessary to determine current infection in a
pregnant woman. This practice has led to a number of women
being incorrectly labeled as HBsAg positive due to misinterpretation
of the results on the lab report. In reporting results,
some labs use the nomenclature "HBsAb" rather than the
more commonly used term "anti-HBs" to designate antibody
to HBsAg. Because the term "HBsAb" is only one character
different from "HBsAg," the lab report is subject to misinterpretation
and a number of "immune" women are incorrectly labeled
as "HBsAg positive". Their infants are given unnecessary
postexposure treatment with hepatitis B immune globulin
(HBIG) and the women experience unnecessary stress. |
|
| Do women who have been
vaccinated previously against HBV infection still need
to be screened during pregnancy? |
|
| Yes. Women who have received
hepatitis B vaccine should still be screened for HBsAg
early with 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 persons, she could have been vaccinated
even though she was already HBsAg positive. |
|
| Is it safe to give
hepatitis B vaccine to a pregnant woman? |
|
| Yes. Limited data indicate
no apparent risk for adverse events to developing fetuses.
Current vaccines contain noninfectious HBsAg and should
cause no risk to the fetus. If the mother is being vaccinated
because she is at risk for HBV infection (e.g., a healthcare
worker [HCW], a person with an STD, an IDU, multiple sex
partners), vaccination should be initiated as soon as her
risk factor is identified during the pregnancy. In contrast,
HBV infection affecting a pregnant woman might result in
severe disease for the mother and chronic infection for
the newborn. |
|
| I've identified a patient
in my OB 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 (i.e., hepatologist, gastroenterologist, infectious disease specialist) should be done. The consulting/referral
physician should be completely 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 antiHBc and HBsAg) as soon as possible. If any are
susceptible to HBV infection (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. |
|
| What can birthing hospitals
do to prevent newborns from "falling through the cracks"
(missing the birth dose) and becoming infected with hepatitis
B? |
|
| The two most important thing
hospitals can do are (1) develop written policies and
procedures for giving the birth dose that
are based on the recommendations of CDC, AAP, and AAFP and (2)
implement the policies and procedures they've developed. By
putting this policy into place, hospitals ensure that every
newborn will receive the birth dose prior to hospital
discharge.
You will find guidelines for implementing birth dose policies
in CDC's recommendations on hepatitis B prevention in children,
which is available at www.cdc.gov/mmwr/pdf/rr/rr5416.pdf. |
|
| Effective hospital policies
and procedures include establishing standardized admission
orders for administration of hepatitis B vaccine as part of
routine medical care of all medically stable infants weighing
2 kg (4.4 lb) or more. You can use IAC's "Admission Orders for
Labor & Delivery and Newborn Units to Prevent Hepatitis B
Virus (HBV) Transmission" (www.immunize.org/catg.d/p2130.pdf)
as a model in developing your hospital's admission orders. |
|
| Note: According to the CDC
recommendations, an order to delay the birth dose until after
hospital discharge can be done on a case-by-case basis and
only in rare circumstances. Further, it requires that a
physician's order to withhold the birth dose and a copy of the
original laboratory report indicating that the mother was
HBsAg negative during this pregnancy be placed in the infant's
medical record. |
|
| Delivery hospitals
should also enroll in the federally funded Vaccines For
Children (VFC) program to obtain free hepatitis B vaccine for
administration of the birth dose to newborns who are eligible
(i.e., Medicaid eligible, American Indian or Alaska Native,
underinsured, or uninsured). The VFC information is available
at www.cdc.gov/vaccines/programs/vfc/default.htm In addition,
many states have made free hepatitis B vaccine available to
all infants at birth to help simplify the process. Call your
state health department to find out if free hepatitis B
vaccine is available at birth for all newborns in your state.
State health department phone numbers are available at www.immunize.org/coordinators. |
|
| Our hospital is dragging
its feet on reinstitution of a policy for the hepatitis
B vaccine birth dose. How can I help convince them that
this is the standard of care? |
|
| Administration of a birth dose
of hepatitis B vaccine is required for effective postexposure
immunoprophylaxis to prevent perinatal HBV infection. Although
infants who require postexposure immunoprophylaxis should
be identified by maternal HBsAg testing, administering
a birth dose to infants, even without HBIG, serves as a "safety
net" to prevent perinatal infection among infants born
to HBsAg-positive mothers who are not identified, because
of errors in maternal HBsAg testing or failure in reporting of
test results. |
|
| The birth dose provides early
protection to infants at risk for infection after the perinatal
period. Although infections in young children represented
less than 10% of all HBV infections before implementation
of routine childhood hepatitis B vaccination, childhood
infections resulted in an estimated 30%-40% of the chronic
HBV infections among persons who acquired their infections
in the United States. Many of these chronic infections
would not have been prevented by a selective program of
identification and immunization of only infants born to
HBsAg-positive mothers. |
|
| CDC recommends that all newborns
be vaccinated in the hospital prior to hospital discharge.
AAP and AAFP have also endorsed these recommendations.
CDC recommends the following with regard to administering
the birth dose: |
|
| • |
|
All delivery
hospitals should implement standing orders for administration
of hepatitis B vaccine as part of routine medical
care of all medically stable infants weighing 2 kg
(4.4 lb) or more at birth. |
| • |
|
All medically stable
infants weighing 2 kg or more at birth and born to
HBsAg-negative mothers should receive the first dose
of vaccine (single-antigen only) before hospital
discharge. |
| • |
|
On a case-by-case
basis and only in rare circumstances, the first dose
may be delayed until after hospital discharge for
an infant who weighs 2 kg or more and whose mother
is HBsAg negative. In this case, a physician's order
not to give the birth dose must be written, and a
copy of the original HBsAg-negative laboratory report
during this pregnancy should be placed in the infant's
medical record. The official CDC recommendations
for hepatitis B vaccination of children are available
at www.cdc.gov/mmwr/pdf/rr/rr5416.pdf. |
|
|
| Administration of a birth dose
has been associated with higher rates of on-time completion
of the hepatitis B vaccine series. In certain populations,
the birth dose has been associated with improved completion
rates for all other infant vaccines. |
|
| For more information, go to www.immunize.org/birthdose. |
|
| If a mother's HBsAg
test result is not available at the time of birth, how
should the infant be managed? |
|
| • |
|
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 born to women without documentation
of HBsAg test results should receive the first dose
of single-antigen hepatitis B vaccine (without HBIG)
by 12 hours of birth. |
| |
|
| • |
|
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. |
| • |
|
If the mother has
never been tested to determine her HBsAg status
and testing is not available (e.g., in remote
locations), the vaccine series should be completed
according to a recommended schedule for infants
born to HBsAg-positive mothers. Administration
of HBIG is not necessary for these infants. |
|
| • |
|
For preterm infants, see the next question |
|
|
| Review the
hepatitis B vaccination recommendations for preterm infants
who weigh less than 2kg (4.4 pounds), as well as for those
premature infants who weigh more. |
|
Preterm infants
weighing less than 2 kg (4.4 lb) at birth have a decreased
response to hepatitis B vaccine 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 hepatitis B vaccination that is
comparable to that of full-term infants.) For preterm infants
weighing less than 2 kg at birth:
|
| • |
|
If maternal
HBsAg status is positive: Give hepatitis B immune
globulin (HBIG) plus hepatitis B vaccine within 12 hours
of birth. Give 3 additional hepatitis B vaccine doses
(with single-antigen vaccine at ages 1, 2-3, and 6
months, or hepatitis B-containing combination vaccine at
ages 2, 4, and 6 months [Pediarix] or 2, 4, and 12-15
months [Comvax]. Test for HBsAg and antibody to HBsAg
1-2 months after completion of at least 3 doses of a
licensed hepatitis B vaccine series (i.e., at age 9-18
months, generally at the next well-child visit). Testing
should not be performed before age 9 months nor within 4
weeks of the most recent vaccine dose. |
| • |
|
If
maternal HBsAg status is unknown: Give HBIG plus hepatitis B
vaccine within 12 hours of birth. Be sure to test the
mother's blood for HBsAg. Give 3 additional hepatitis B
vaccine doses (with single-antigen vaccine at ages 1,
2-3, and 6 months, or hepatitis B-containing combination
vaccine at ages 2, 4, and 6 months [Pediarix] or 2, 4,
and 12-15 months [Comvax]. |
| • |
|
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 hepatitis B
vaccine until age 1 month or hospital discharge,
whichever comes first. Complete the vaccine series per
the recommended schedule. |
|
For preterm infants weighing 2
kg or more at birth, follow the
recommendations for full-term infants including the birth dose
for all, keeping in mind the special needs of newborns whose
mother's HBsAg status is positive or unknown. |
| |
| I'm a pediatrician
and support the use of the birth dose of hepatitis B
vaccine. I give it routinely, but a few parents object.
In my practice, almost 100% of my infant patients' mothers
are tested for HBsAg and almost all are reported to be
negative. Could you tell me how many cases of HBV infection
occur each year in babies who are born to documented
HBsAg-negative mothers? |
|
| Because infants born to HBsAg-negative
mothers are usually not tested for HBV infection, and because
virtually all HBV infections occurring among infants are
asymptomatic, it is not possible to quantify the number
of HBV-infected infants born to mothers believed to be
HBsAg negative. However, we know that many unvaccinated
newborns have been left needlessly at risk of infection
because of errors in maternal hepatitis B testing and reporting.
In two surveys conducted by IAC covering the period from
July 1999 to October 2002, state and local hepatitis B
coordinators reported more than 500 medical errors discovered
through their perinatal hepatitis B prevention programs.
Many of these errors involved misinterpreting or mistranscribing
hepatitis screening test results, or ordering the wrong
hepatitis B screening test. Such errors can lead to a mother
being documented as HBsAg negative, when she is actually
HBsAg positive. Use of the hepatitis B vaccine birth dose
safeguards against these maternal hepatitis B testing and
reporting errors and also prevents early childhood HBV
infections. The birth dose also protects the infants of
women who become HBV infected after having been screened
in early pregnancy and not tested later in pregnancy. |
|
| Preventing possible HBV transmission
in early childhood is also a major issue. Seroprevalence
data from the National Health and Nutrition Examination
Surveys have provided estimates of the number of early
HBV infections. Based on these data, approximately 16,000
children under 10 years of age were infected with HBV beyond
the postnatal period each year before routine infant vaccination
was recommended in 1991 (Armstrong GL, Mast EE, Wojczynski
M, Margolis HS. Childhood hepatitis B virus infections
in the United States before hepatitis B immunization. Ped.
200l;108(5):1123-28). Although these infections represented
only 5%-10% of all persons with chronic HBV infection in
the United States at that time, it is estimated that 18%
of all persons with chronic HBV infection acquired their
infections postnatally during early childhood. In some
populations, childhood transmission was more important
than perinatal transmission as a cause of chronic HBV infection
before infant hepatitis B immunization was widely implemented.
For example, in studies conducted among children born in
the United States with Southeast Asian refugee parentage
during the 1980s, approximately 60% of chronic HBV infections
in young children were among children born to HBsAg-negative
mothers. Since implementation of routine childhood immunization,
an estimated 6,800 perinatal HBV infections have been prevented
in the United States annually. |
|
| Should states and localities
establish case-management programs to prevent perinatal
HBV infection? |
|
| Yes. Case-management programs
should be established that include appropriate policies,
procedures, laws, and regulations to ensure that all pregnant
women are tested for HBsAg during each pregnancy and that
infants born to HBsAg-positive women and infants born to
women with unknown HBsAg status receive recommended case
management. The location of these programs and the methods
by which they operate will depend on multiple factors (e.g.,
population density and annual caseload of HBsAg-positive
women). Programs might be located in state or local health
departments, private healthcare systems (e.g., health maintenance
organizations), or institutions (e.g., correctional facility
systems). Program administrators will need to work with
prenatal care providers, delivery hospital staff, pediatric
care providers, private healthcare systems, and health
departments. |
|
| Does a birth dose of
vaccine increase the risk of elevated temperature and
subsequent microbiologic evaluations? |
|
| No. Administration of hepatitis
B vaccine 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. |
|
| 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 hepatitis B vaccine within
12 hours of birth. Although HBsAg can be detected in breast
milk, studies done before hepatitis B vaccine 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 postexposure prophylaxis
to prevent perinatal HBV infection, there is no increased
risk of infection among breastfed infants. |
|
| What is the possibility
of maternal HBV transmission when breastfeeding an infant
if the mother is HBsAg positive and has cracked or bleeding
nipples? |
|
| As stated before, although
HBsAg can be detected in breast milk, there is no evidence
that HBV is transmitted by breastfeeding. Babies born to
HBsAg-positive mothers should be immunized with hepatitis
B vaccine and HBIG, which will substantially reduce the
risk of perinatal transmission and protect the infant from
modes of postnatal HBV transmission, including the theoretical
exposure to HBV from cracked or bleeding nipples during
breastfeeding. To prevent cracked and bleeding nipples,
all mothers that breastfeed should be instructed on proper
nipple care. |
|
| Can Comvax or
Pediarix be given at birth? |
|
| No. Neither of these combination
vaccines should be given before age 6 weeks. The use
of Comvax prior to age 6 weeks can cause
the suppression of the immune response to the Hib component
in Comvax. The use of Pediarix prior
to age 6 weeks can result in suppression of the immune
response to the acellular pertussis component of Pediarix. |
|
| Is it acceptable to
give a 4-dose schedule of hepatitis B vaccine to infants? |
|
| Yes. The use of a 4-dose
hepatitis B vaccine schedule is necessary when giving the monovalent
hepatitis B vaccine birthdose followed by the use of combination
vaccines Comvax or Pediarix. The use of a 4-dose hepatitis
B vaccine 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 VFC
program provides up to four doses of hepatitis B vaccine
for VFC-eligible children. You may still use monovalent
hepatitis B vaccine in a 3-dose series. |
|
| An infant was
given monovalent hepatitis B vaccine (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 age 6
months (no earlier than age 24 weeks). See the next question for more information on this issue. |
|
| What is the earliest
age the last dose of hepatitis B vaccine can be given
to an infant? |
|
| The minimum age for the last
dose of hepatitis B vaccine should not be prior to 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 change allows health professionals
more flexibility in administering hepatitis B vaccine should
a parent bring an infant in for a well-baby check before
the infant reaches a full 6 months of age. There is a 4-day
grace period for this dose; therefore, the earliest age
at which the last dose of hepatitis B vaccine is acceptable
is 164 days of age (168 days [24 weeks] minus the 4-day
grace period). If the third dose is given prior to the
minimum age, then that dose should not be counted. Poorer
response rates are seen in infants who complete the vaccination
series prior to age 24 weeks; therefore, the third dose
should be repeated when the infant is at least age 24 weeks. |
|
| 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 an HBsAg-positive mother? |
|
| For infants born to HBsAg-positive
mothers, postvaccination testing is recommended 1-2 months
after completion of at least 3 doses of a licensed hepatitis B
vaccine series (i.e., at age 9-18 months, generally at the
next well-child visit). Testing should not be performed before
age 9 months, as HBIG might still be present for 6-8 months
nor should testing be performed within 4 weeks of the most
recent vaccine dose, as a false positive HBsAg might occur.
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. |
|
| HBsAg-negative infants with
anti-HBs levels of at least 10 mIU/mL are protected and need
no further medical management. HBsAg-negative infants with
anti-HBs levels less than 10 mIU/mL should be revaccinated
with a second 3-dose series and retested 1-2 months after the
final dose of vaccine. Children who are HBsAg positive should
receive medical evaluation and ongoing follow-up. |
|
| An infant of an HBsAg-positive
mother received appropriate postexposure prophylaxis and
tested negative for anti-HBs and HBsAg at 12 months of age.
How many more doses of hepatitis B vaccine do I need to give
before I retest? |
|
| The recommended approach is to
complete a second 3-dose series of vaccine and re-test for
both HBsAg and anti-HBs 1-2 months after the third dose of
vaccine. If anti-HBs and HBsAg are still negative after
revaccination, the child is considered a non-responder to
hepatitis B vaccine. |
|
| When screening an adopted
infant for hepatitis B, at what age would you expect
the infant to not show anti-HBs or anti-HBc if it were
passively transferred antibody from the mother? |
|
| Passively acquired maternal
anti-HBs might be detected until age 6-8 months and passively
acquired maternal anti-HBc might be detected until age
24 months. |
|
| All foreign-born persons (including
immigrants, refugees, asylum seekers, and internationally
adopted children) born in Asia, the Pacific Islands, Africa,
and other regions with high endemicity of HBV infection
should be tested for HBsAg, regardless of vaccination status.
Persons testing HBsAg positive should be referred for
medical evaluation and ongoing follow-up. |
| |
|
|
| Child and teen hepatitis B vaccination issues |
Back to top |
|
|
|
| Should all children
ages 0 through 18 years be vaccinated against hepatitis
B? |
|
| Yes. CDC recommends
that all children ages 0-18 years be fully vaccinated
with hepatitis B vaccine. 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/recs/schedules/child-schedule.htm).
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 less 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 screened for HBsAg and have a review of their immunization record 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 (equal or greater than 40
years). 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 hepatitis B vaccine 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 now and be sure there
are at least 8 weeks between that dose and the third dose.
No apparent effect on immunogenicity has been documented
when minimum spacing of doses is not achieved precisely.
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 persons 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 adolescents. |
|
| Using the approved 2-dose schedule,
the adult dose of Recombivax HB (1.0 mL
dose containing 10 mcg of HBsAg) is administered to adolescents
ages 11-15 years, with the second dose given 4-6 months
after the first dose. In immunogenicity studies among adolescents
ages 11-15 years, antibody concentrations and end seroprotection
rates (at least 10 mIU/mL of anti-HBs) were similar with
the 2-dose schedule and the currently licensed 3-dose schedule
(0.5 mL dose containing 5 mcg of HBsAg). The overall frequency
of adverse events was similar for the 2-dose schedule compared
to the 3-dose schedule. Short-term (two-year) follow-up
data indicate that the rate of decline in antibody levels
for the 2-dose schedule was similar to that for the 3-dose
schedule. No data are available to assess long-term protection
(beyond 2 years) or immune memory following vaccination
with the 2-dose schedule, and it is not known whether booster
doses of vaccine will be required. As with other hepatitis
B 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 dose of 5 mcg 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. |
|
| How should we complete
the series if a 12-year-old child 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 licensed for use in children ages 11-15 years.
Thus, a 16-year-old child would need two additional doses
of pediatric hepatitis B vaccine 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? |
|
| It depends on the schedule and manufacturer of the vaccine that you are using. For 11-15 year old
children, the 2-dose Recombivax HB volume
is 1.0 mL or 10 micrograms. Otherwise the 3-dose schedule
of both Recombivax HB and Engerix-B is
0.5 mL or 5 micrograms. 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
persons (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 vaccination of immigrant
children should not be delayed while awaiting hepatitis B test
results. All persons found to be HBsAg positive should have
ongoing medical management by a physician knowledgeable about
hepatitis B and its complications. |
| |
|
|
|
|
| According to the CDC hepatitis B recommendations for adults,
which adults should be vaccinated? |
|
| The following groups are
recommended for hepatitis B vaccination: |
|
| • |
|
Sex partners
of HBsAg-positive persons |
| • |
|
Sexually
active persons who are not in long-term, mutually
monogamous relationships |
| • |
|
Persons seeking evaluation
or treatment for an STD |
| • |
|
Persons 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 should receive appropriate management. |
| • |
|
Men who have sex with
men (MSM) |
| • |
|
Current or recent
illegal injection drug users |
| • |
|
Household contacts of
HBsAg-positive persons |
| • |
|
Residents and staff of
facilities for developmentally challenged persons |
| • |
|
Healthcare and public
safety workers with reasonably anticipated risk for
exposure to blood or blood-contaminated body fluids |
| • |
|
Persons 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 http://wwwn.cdc.gov/travel/default.aspx for
countries with intermediate or high levels of HBV infection |
| • |
|
Persons with chronic
liver disease |
| • |
|
Persons with HIV infection |
| • |
|
All other persons 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 hepatitis B vaccination of adults
are available at www.cdc.gov/mmwr/PDF/rr/rr5516.pdf. |
|
| In which adult healthcare
setting(s) is hepatitis B vaccination recommended routinely? |
|
| In certain settings, a high
proportion of persons are likely to be at risk for HBV
infection. Examples of these settings are the following: |
|
| • |
|
STD/HIV testing
and treatment facilities |
| • |
|
Drug-abuse
treatment and prevention settings including injection-drug-user
care settings |
| • |
|
Healthcare settings targeting
services to MSM |
| • |
|
Correctional facilities |
| • |
|
Chronic hemodialysis
facilities and end-stage renal disease programs |
| • |
|
Institutions and non-residential
day care facilities for developmentally challenged
persons |
|
|
| In these settings, CDC recommends
universal hepatitis B vaccination for all adults who have
not completed the vaccine series. Certain persons with
risk factors (e.g., MSM and IDUs) should be vaccinated
against hepatitis A, as well. Although a risk assessment
is not required in these settings before offering and encouraging
hepatitis B vaccine, it still might be useful, and especially
for consideration of hepatitis A vaccine, given that not
all persons visiting these settings are recommended to
receive hepatitis A vaccine. |
|
| For your use, a hepatitis A
vaccination screening questionnaire is available at: www.immunize.org/catg.d/p2190.pdf. A
hepatitis B vaccination screening questionnaire is available
at: www.immunize.org/catg.d/p2191.pdf. |
|
| How should hepatitis B
vaccination be managed in primary care and specialty medical settings? |
|
| In primary care and specialty
medical settings, CDC recommends implementation of standing
orders for identifying adults recommended for hepatitis
B vaccination and for administering vaccination as part
of routine services. To ensure vaccination of adults at
risk for HBV infection who have not completed the vaccine
series, CDC recommends the following: |
|
| • |
|
Provide information
to all adults regarding the health benefits of hepatitis
B vaccination, including risk factors for HBV infection
and persons for whom vaccination is recommended |
| • |
|
Help all
adults assess their need for vaccination by obtaining
a history that emphasizes risks for sexual transmission
and percutaneous or mucosal exposure to blood |
| • |
|
Vaccinate all adults
who report risk(s) for HBV infection |
| • |
|
Vaccinate all adults
requesting protection from HBV infection, without
requiring them to acknowledge a specific risk factor |
|
|
| For your use, a hepatitis B
vaccination screening questionnaire is available at www.immunize.org/catg.d/p2191.pdf. Standing
orders for administering hepatitis B vaccine to adults
are also available at www.immunize.org/catg.d/p3076.pdf. |
|
| 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 gluteus muscle should not be used as a site for administering hepatitis
B vaccine. The suggested needle size is 1"--2" depending on the recipient's gender and weight (1" for females weighing less than 70 kg; 1-1/2" for females weighing
70-100 kg; 1"--1-1/2" for males weighing less than 120 kg; and 2" for males weighing 120 kg or more and females more than 100 kg). A 22- to 25-gauge needle should
be used. For optimal protection, it is crucial that the vaccine be administered IM, not subcutaneously. |
|
| I want to be
able to start vaccinating adults at increased risk
of HBV infection in our clinic; however, we know that
many of them are uninsured or have minimal insurance
coverage. Is there any way that we can get free vaccine
from CDC? |
|
| The availability of free
vaccine is variable. Some states have
special programs that make hepatitis B vaccine available
for certain groups of adults with increased risk of HBV
infection. Check with your state immunization program
manager or hepatitis B coordinator on the availability
of low-cost or free vaccine. A list of state immunization
program managers and a list of hepatitis B coordinators is available at: www.immunize.org/coordinators. |
| |
| Is post-vaccination
testing needed for adults who receive hepatitis B vaccine? |
|
| Serologic testing for immunity after
vaccination is recommended only for persons whose subsequent
clinical management depends on knowledge of their immune
status. Testing is not necessary after routine vaccination
of adults. |
|
| Post-vaccination testing is
recommended for the following: Healthcare and public safety
workers at high risk of continued exposure to blood on
the job; immune compromised persons; and sex or needle-sharing
partners of HBsAg-positive persons. Testing should be performed
1-2 months after the last dose of vaccine. |
| |
| If a person has been
sexually assaulted, should he/she be offered HBIG and
hepatitis B vaccine? |
|
| There have been no studies
to determine the risk of HBV infection following sexual
assault; however, it is known that other STDs are transmitted
following such episodes. Therefore, post-exposure prophylaxis
to victims of sexual assault should be provided. Unless
the victim has a documented history of completed hepatitis
B vaccination, hepatitis B vaccine alone on a 0-, 1-, 6-month
vaccination schedule should be administered with the first
dose as soon as possible after the assault. There is no
need to give HBIG for the following reasons: 1) vaccine
alone has high efficacy in post-exposure prophylaxis in
persons exposed to chronic HBV infection; 2) HBIG is only
needed to improve efficacy of postexposure prophylaxis
of sex contacts of persons with acute HBV infection. In
most cases, it could be assumed that if the rapist were
HBV infected, he/she would have chronic HBV infection,
not acute HBV infection, and hence might be less infectious. |
|
| For details, please refer to
Appendix B of CDC's adult hepatitis B recommendations at: www.cdc.gov/mmwr/PDF/rr/rr5516.pdf. |
| |
| How often do hemodialysis
patients who have received hepatitis B vaccination have
to be tested for anti-HBs and HBsAg? |
|
| Recommendations for immune
compromised persons, 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 three or four additional doses
of hepatitis B vaccine (depending on the brand) using the
dialysis specific dosing regimen. 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 1-2 months after the vaccine series) to
hepatitis B 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 hepatitis B vaccine
should be given and annual anti-HBs testing should be continued.
Retesting immediately after the booster dose is not necessary.
If the patient continues to have low (less than 10 mIU/mL)
or no anti-HBs and a total of six or eight doses (depending
on the brand) of hepatitis B vaccine have been given, the
patient should be considered a non-responder to vaccination
and susceptible to HBV infection. Monthly HBsAg testing
should be continued and no periodic anti-HBs testing is
needed. |
|
| 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 U.S., Twinrix
is licensed for use in people who are age 18 years or older. It can be
administered to persons who
are at risk for both hepatitis A and hepatitis B, such as certain international
travelers, men who
have sex with men, illegal drug users, or to persons who simply want to be
immune to both diseases.
Primary immunization 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, 21-30 days,
and 12 months). The
4-dose schedule could benefit individuals needing rapid protection from
hepatitis A and hepatitis
B, such as persons traveling to high-prevalence areas imminently and emergency
responders,
especially those being deployed to disaster areas overseas. Twinrix cannot be
used for postexposure
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 persons age 18 years and older. If Twinrix is not available or if
you choose not to use Twinrix to complete the Twinrix series, you should
do the following: If 1 dose of Twinrix was given, complete the series
with 2 adult doses of hepatitis B vaccine and 2 adult doses of hepatitis
A vaccine. If 2 doses of Twinrix were given, complete the schedule with
1 adult dose of hepatitis A vaccine and 1 adult dose of hepatitis B
vaccine.
Another way to consider this is as
follows:
A dose of Twinrix contains a standard adult dose of hepatitis B vaccine
and a pediatric dose of
hepatitis A vaccine. Thus, a dose of Twinrix can be substituted for any
dose of the hepatitis B
series but not for any dose of the hepatitis A series.
| • |
|
Any combination of 3 doses of adult
hepatitis B or 3 doses of Twinrix = a complete series of hepatitis B
vaccine |
| • |
|
One dose of Twinrix
+ 2 doses of adult hepatitis A = a complete series of
hepatitis A vaccine |
| • |
|
Two doses of Twinrix + 1
dose of adult hepatitis A = a complete series of
hepatitis A vaccine |
|
|
| 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 hepatitis A vaccine
[720 vs. 1440 El. U.], so the patient would not receive the recommended
dose of hepatitis A vaccine antigen. For this reason, 3 doses of Twinrix
must comprise the series. |
| |
|
|
|
|
| Which workers in the
healthcare setting need hepatitis B vaccine? |
|
| The Occupational Safety and Health Administration (OSHA) requires that hepatitis B vaccine be offered to healthcare workers (HCWs) who have a reasonable expectation of being exposed to blood on the job. This requirement does not include HCWs who would not be expected to have occupational risk, such as receptionists,
billing staff, and general office workers. |
|
| If a HCW had one dose only of hepatitis B vaccine 4 months ago, should the series be restarted? |
|
| No. The hepatitis B vaccine series should not be restarted when doses are delayed; rather, the series should be continued from where it stopped. The HCW should receive the second dose of vaccine now and the third dose at least 8 weeks later. There needs to be at least 16 weeks between the first and the third doses and at least
8 weeks between the second and third doses of vaccine. |
|
| Is it safe for HCWs to be vaccinated during pregnancy? |
|
| Yes. Limited data indicate no apparent risk for adverse events to developing fetuses. Current hepatitis B vaccines contain noninfectious hepatitis B surface antigen
(HBsAg) and should pose no risk to the fetus. If the mother is being vaccinated because she is at risk for hepatitis B virus (HBV) infection (e.g., a HCW, a person with a sexually transmitted disease, an injection drug user, multiple sex partners), vaccination should be initiated as soon as her risk factor is identified during the pregnancy. If not vaccinated, a pregnant woman may contract an HBV infection, which might result in severe disease for the mother and chronic infection for the newborn. In addition, giving hepatitis B vaccine to the mother is not a contraindication to breastfeeding. |
|
| Which HCWs need serologic testing after receiving 3 doses of hepatitis B vaccine? |
|
| All HCWs who have a reasonable risk of exposure to blood or body fluids containing blood (e.g., HCWs with direct patient contact, HCWs who have the risk of needlestick or sharps injury, laboratory workers who draw or test blood) 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. |
|
| What should be done if a HCW's postvaccination anti-HBs test is negative 1-2 months after the last dose of vaccine? |
|
| Repeat the 3-dose series and test for anti-HBs 1-2 months after the last dose of vaccine. If the HCW is still negative after a second vaccine series, the HCW is considered a non-responder to hepatitis B vaccination. HCWs who do not respond to vaccination should be tested for HBsAg to determine if they have chronic HBV
infection. If the HBsAg test is positive, the person should receive appropriate counseling and medical management. Persons 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 hepatitis B immune globulin
(HBIG)
prophylaxis for any known or likely exposure to HBsAg-positive blood. |
|
| How often should I test HCWs after they've received the hepatitis B vaccine series to make sure they're protected? |
|
| For immune competent HCWs, periodic testing or periodic boosting is not needed. Postvaccination testing (anti-HBs) should be done 1-2 months after the last dose of hepatitis B vaccine. If adequate anti-HBs (at least 10 mIU/mL) is present, nothing more needs to be done. If postvaccination testing is less than 10 mIU/mL, the vaccine
series should be repeated and anti-HBs testing done, 1-2 months after the last dose of the second series. This information should be recorded in the HCW's employee
health record. |
|
| Should a HCW 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. Immune competent persons known to have responded to hepatitis B vaccination 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 HCW
was protected. Substantial evidence suggests that adults who
respond to hepatitis B vaccination (anti-HBs of at least 10 mIU/mL)
are protected from chronic HBV infection for more than 20 years,
even if there is no detectable anti-HBs currently. Only
immunocompromised persons (e.g., hemodialysis patients, some
HIV-positive persons) need to have anti-HBs testing and booster
doses of vaccine to maintain their protective anti-HBs
concentrations of at least 10 mIU/mL. |
|
| Before reading the recommendations of CDC's Advisory Committee on Immunization Practices (ACIP) that say not to do this, we tested our employees for anti-HBs several years after
they were vaccinated and some people had inadequate results, even though they had all completed a 3-dose series. What should we do now? |
|
| The ACIP guidelines do not
address this situation; however, we know that anti-HBs
concentrations decline over time and immunocompetent HCWs who
had anti-HBs levels >10 mIU/mL 1-2 months after primary
vaccination series remain protected even if their anti-HBs
concentration declines to below 10 mIU/mL. There are several
options to consider for immunocompetent HCWs in this situation,
depending on cost considerations, anticipated high risk of
exposure (including medical trainees), and employee/employer
desire for documented immunity: |
| • |
|
Administering
an additional dose of vaccine followed by serological
testing (and then two subsequent doses if titers are
non-protective followed by serological testing); |
| • |
|
Administering
an additional 3-dose series followed by serological
testing 1-2 months after the third dose (and if titers are
still non-protective, counseling about the importance of
seeking care after a potential exposure); or |
| • |
|
Do not test or vaccinate
further at this time but counsel regarding the importance
of seeking immediate assessment after percutaneous or
mucosal exposure to blood or blood containing body fluids,
and following the guidelines for post-exposure management
(see postexposure guidelines,
Table 3). |
|
|
| How often should anti-HBs testing be done on HCWs who perform invasive procedures? |
|
| For persons whose immune status is normal, periodic serologic testing to assess anti-HBs concentrations is not necessary. Persons who perform invasive procedures should be treated no differently from other HCWs with respect to anti-HBs testing. If a HCW has an exposure (e.g., needlestick), s/he should be evaluated for their need for immunoprophylaxis according to postexposure guidelines in Table 3. |
|
| If HCWs received hepatitis B vaccination in the past and were not tested for immunity, should they be tested now? |
|
| No. In this scenario, a HCW does not need to be tested unless s/he has an exposure. If an exposure occurs, refer to the postexposure guidelines in Table 3. |
|
| How should a vaccinated HCW with an unknown anti-HBs response be managed if they have a percutaneous or mucosal exposure to blood or body fluids from an HBsAg-positive
source? |
|
| This person should be tested for anti-HBs as soon as possible after exposure. If the anti-HBs concentration is at least 10 mIU/mL, no further treatment is needed. If the anti-HBs concentration is less than 10 mIU/mL, HBIG and one dose of hepatitis B vaccine should be administered. Prior to administering the HBIG and vaccine, blood should be drawn for a baseline HBsAg test. Subsequently, in 3-6 months, an additional anti-HBs and an HBsAg test should be performed. If the HBsAg is positive,
the person is infected and should be referred for medical evaluation. If the anti-HBs result is at least 10 mIU/mL, the person is seroprotected. It is necessary to do postvaccination testing later than the usual recommended time frame because anti-HBs from HBIG might be detected if testing is done any earlier. The postvaccination
test result should be recorded in the person's health record. |
|
| For a pre-employment physical, a HCW states she received all three hepatitis B vaccine doses as an adolescent. Would you test for anti-HBs? |
|
| If the HCW has written documentation of a full hepatitis B vaccine series, testing for anti-HBs at this point is not necessary. If the HCW has a subsequent exposure
to HBV, hepatitis B immunoprophylaxis should be administered following
guidelines for a person who has been vaccinated, but the
immune response is not known (Table
3). This information should be documented in the HCW's employee health record. This approach should be sufficient to meet the needs of the employer and the requirements of OSHA. If there is no written documentation of hepatitis B vaccination, see the next question. |
|
| 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, the 3-dose vaccination series should be administered and postvaccination testing should be performed 1-2 months after the third dose of vaccine. There is no harm in receiving extra doses of vaccine. Care should always be taken to document vaccine lot, date, manufacturer, route, and vaccine dosages. Postvaccination testing results should also be documented, including the date testing was performed. All organizations (e.g., hospitals, clinics) should
develop policies or guidelines to assure valid hepatitis B immunization. |
|
|
|
|
|
| A healthcare worker (HCW) 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? |
|
| A positive anti-HBs indicates that the vaccinated person is immune at the time the HCW was tested, but does not necessarily assure that the HCW has long-term immunity. Long-term immunity has been shown only for persons attaining an adequate anti-HBs result of at least 10 mIU/mL after a 3-dose vaccination series. The most direct way to deal with this is to vaccinate the HCW with the 3-dose series of hepatitis B vaccine; test for anti-HBs in 1-2 months and document the result in the HCW's employee health record. An adequate anti-HBs result from a documented 3-dose vaccine series would assure not only seroprotection, but long-term protection,
as well. |
|
| Of course, it is possible that the HCW has an anti-HBs result of greater than 10 mIU/mL because of an HBV infection in the past. If this is of concern, a total anti-HBc
test could be performed to discern this (a positive result indicates a history of HBV infection at some undefined period in time). |
|
| 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? |
|
| Nothing. Data show that vaccine-induced anti-HBs levels might decline over time; however, immune memory (anamnestic anti-HBs response) remains intact indefinitely
following immunization. Persons with anti-HBs concentrations that decline to less than 10 mIU/mL are still protected against HBV infection. For HCWs with normal
immune status who have demonstrated adequate anti-HBs (at least 10 mIU/mL) following vaccination, booster doses of vaccine or periodic anti-HBs testing is not recommended. |
|
| A person who is a known non-responder to hepatitis B vaccine has a percutaneous exposure to HBsAg-positive blood. According to older ACIP recommendations, I have the option to
give HBIG x 2 or HBIG x 1 and initiate revaccination. How do I decide which to do? |
|
| Current recommendations have been revised. The recommended postexposure prophylaxis for persons who are non-responders to hepatitis B vaccine (i.e., have not
responded to an initial 3-dose series and revaccination with a 3-dose series) is to give HBIG as soon as possible after exposure and a second dose of HBIG one month
later (see Table 3). Exposed persons, who are known not to have responded to a primary vaccine series, but have not been revaccinated with a second 3-dose series,
should receive a single dose of HBIG and reinitiate the hepatitis B vaccine series with the first dose of hepatitis B vaccine as soon as possible after exposure. |
|
| If an employee does not respond to hepatitis B vaccination (employee has had two full series of hepatitis B vaccine), 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 the vaccine? |
|
| 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. HCWs who do not respond to vaccination should be tested for HBsAg to determine if they have chronic HBV infection.
If the HBsAg test is positive, the person should receive appropriate counseling and medical management. Persons 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). |
|
| Can a person with chronic HBV infection become a HCW? |
|
| Yes. All HCWs should practice standard precautions, which are designed to prevent HBV transmission, both from patients to HCW and from HCW to patient. There is, however, one caveat concerning HBV-infected HCWs. Those who are HBsAg positive and HBeAg (hepatitis B e antigen) positive should not perform exposure-prone
procedures (e.g., 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. Such circumstances might include notifying prospective patients of the HCW's seropositivity before they undergo
exposure-prone invasive procedures. For more information on this issue, see the Mortality and Morbidity Weekly Report, "Recommendations for Preventing Transmission
of Human Immunodeficiency Virus and Hepatitis B Virus to Patients During Exposure-Prone Invasive Procedures," MMWR, 7/12/91, Vol. 40(RR-8);1-9. This document
is available at www.cdc.gov/mmwr/preview/mmwrhtml/00014845.htm. |
| |
|
|
|
|
| What does the term "chronic
hepatitis B virus infection" mean? |
|
| Chronic infection with HBV
means that you have a long-term HBV infection; your body
did not get rid of the virus when you were first infected
with HBV. The risk of progressing to chronic infection
is age dependent (i.e., 2% to 6% of people over age 5
years; 30% of children age 1-5 years; and up to 90% of
infants). People with chronic infection can infect others
and are at increased risk of serious liver disease including
cirrhosis and liver cancer. In the United States, an estimated
1.25 million people are chronically infected with HBV. |
|
| A person is
considered to have chronic HBV infection if he or she is (1)
HBsAg positive on two occasions at least 6 months apart, or
(2) HBsAg positive and IgM class anti-HBc (antibody to
hepatitis B core antigen) negative on a single blood draw. (An
IgM class anti-HBc test will be positive for 4-6 months after
acute HBV infection.) For information on the recommendations
for identification and public health management of persons
with chronic hepatitis B virus infection see: www.cdc.gov/mmwr/preview/mmwrhtml/rr5708a1.htm |
|
| What are some important
Do's and Don'ts for people with chronic HBV infection? |
|
| DO's |
|
| • |
|
Cover all
cuts and open sores with a bandage. |
| • |
|
Discard used
items such as bandages and menstrual pads carefully
so no one is accidentally exposed to your blood. |
| • |
|
Wash hands well after
touching your blood or infectious body fluids. |
| • |
|
Clean up blood spills.
Then clean the area again with a bleach solution
(one part household chlorine bleach to 10 parts of
water). |
| • |
|
Tell your sex partner(s)
you have hepatitis B so they can be tested and vaccinated
(if not already infected or vaccinated). Partners
should be tested after three doses of vaccine are
completed to be sure the vaccine worked. |
| • |
|
Use condoms (rubbers)
during sex unless your sex partner has had hepatitis
B or has been immunized and has had a blood test
demonstrating immunity to HBV infection. (Condoms
might also protect you from other sexually transmitted
diseases). |
| • |
|
Tell household members
to see their doctors for testing and vaccination
for hepatitis B. |
| • |
|
Tell your doctors that
you are chronically infected with HBV. |
| • |
|
See your doctor every
6-12 months to check your liver for abnormalities,
including cancer. |
| • |
|
If you are pregnant,
tell your doctor that you have HBV infection. It
is critical that your baby is started on hepatitis
B shots within a few hours of birth. |
|
|
| DONT's |
|
| • |
|
Don't share
chewing gum, toothbrushes, razors, washcloths, needles
for ear or body piercing, or anything that might
have come in contact with your blood or infectious
body fluids. |
| • |
|
Don't pre-chew
food for babies. |
| • |
|
Don't share syringes
and needles. |
| • |
|
Don't donate blood, plasma,
body organs, tissue, or sperm. |
|
|
| Should all HBsAg-positive
adults and children be referred to specialists in liver
disease (e.g., hepatologists)? |
|
| All HBsAg-positive adults and
children should have a medical evaluation to determine
whether they have active liver disease (e.g., liver enzymes,
biochemical tests of liver function) and whether they are
candidates for antiviral therapy. Depending on your practice
situation or setting, this can be done by referral or consultation
with a physician knowledgeable about chronic viral hepatitis
(i.e., hepatologist, infectious disease specialist, gastroenterologist). |
|
| I understand that if
a person is HBeAg negative and HBsAg positive, s/he is
not infectious. Am I correct? |
|
| No, you are incorrect! HBsAg-positive
people are infectious independent of their HBeAg status.
HBeAg-positivity indicates higher levels of HBV in the
blood compared to an HBeAg-negative person. A person who
is HBsAg positive and HBeAg negative is still infectious,
but has lower levels of HBV in their blood. |
|
| I have had patients
tell me that their doctor said their HBV infection is "in
remission." Would you please comment on the appropriateness
of this terminology? |
|
| "Remission" is not a good term
to be used for a persistent infection, such as HBV. HBV
infection should be described in terms of virologic markers,
infectivity, and evidence of liver disease. Some persons
might resolve their infection (i.e., become HBsAg negative,
and hence are not infectious) spontaneously or from antiviral
therapy. Other persons might remain HBsAg positive and
hence infectious, but have no evidence of chronic liver
disease (i.e., the often used term "healthy carriers").
We assume that the use of "remission" in the question might
refer to either of these scenarios. |
|
| Does giving hepatitis
B vaccine to a chronically infected person cause any
harm? |
|
| No, it will neither harm nor
help the person. |
|
| What are possible risk
factors for developing liver disease among persons with
chronic HBV infection? |
|
| Older age, male gender, presence
of HBeAg, HBV genotype, mutations in the precore and core
promoter regions of the viral genome, and coinfection with
hepatitis D (delta) virus. An association between alcohol
use and progression to hepatocellular carcinoma in persons
with chronic hepatitis B has been reported in some studies,
but not in others; these discrepancies might be related
to accuracy of the alcohol history. |
|
| We have a 12-year-old
patient who has been HBsAg positive since infancy. Now
that the state requires proof of hepatitis B vaccination,
what do we do? His mom is less than enthusiastic about
telling the school that he is HBsAg positive, and I can't
find any recommendations on vaccinating kids in this
situation. |
|
| We would not vaccinate the
child. You should check with your state health department,
as states might be different in what they require for declination
of vaccination. Depending on state regulations, as the
child's physician, you could provide the school with a
letter stating that hepatitis B vaccination is contraindicated
for the child. There is no need to add that the child is
HBsAg positive. |
| |
| Reviewed on 11/09 |
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