View Clinical Trial (Medical Research Study)
Duration of Long-Term Immunity After Hepatitis B Virus Immunization
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Hepatitis B |
| Purpose: |
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Background:
- The hepatitis B vaccine has been shown to be safe and effective in preventing
transmission of the hepatitis B virus. Response rates to the initial three doses of the
vaccine are high, with significant or even complete immune response. However, this
level has been reported to decline rapidly within the first year and more slowly
thereafter. There is little data on the durability and long-term protection provided by
the hepatitis B vaccine administered to adults in the United States.
- Vaccinated individuals are believed to be protected against hepatitis B virus infection
because of a memory immune response. Even if antibody levels are low, the immune system
will still be able to produce enough antibody to neutralize the hepatitis B virus.
Therefore, booster doses of the vaccine are not recommended, except for some high-risk
individuals such as patients on dialysis. Researchers are interested in determining the
durability of the immune response of the hepatitis B vaccine in adults with low or
intermediate risk for hepatitis B virus infection.
Objectives:
- To examine the long-term immune status of human immunodeficiency virus (HIV) positive and
negative individuals who received the hepatitis B vaccine during adulthood, compared with
the immune status of individuals who acquired natural immunity by recovering from acute
hepatitis B during adulthood.
Eligibility:
- Individuals at least 18 years of age who were vaccinated against hepatitis B at least
10 years ago.
- Individuals at least 18 years of age who contracted and recovered from acute hepatitis
B at least 10 years ago.
- Individuals at least 18 years of age who have well-controlled HIV and were vaccinated
against hepatitis B at least 10 years ago.
Design:
- Participants will have a single outpatient study visit and potential follow-up visits
as part of this protocol.
- Participants will complete a questionnaire assessing possible risk factors for
hepatitis B infection, and will provide blood samples to test for hepatitis B
antibodies and other immune system studies.
- Participants will receive a letter or phone call with the results of the blood tests:
- Those who no longer have protective levels of antibody against the hepatitis B virus
will be offered a booster dose of the hepatitis B vaccine. To monitor immune response
to the booster vaccine, additional study visits will be scheduled at 1 and 3 weeks
following the booster.
- Those who have chronic infection with the hepatitis B virus will be advised to follow
up with their primary care physician, and may be eligible to participate in ongoing
treatment trials for chronic hepatitis B.
- Those who have abnormal blood tests will be referred back to their primary care
physician for investigation of the abnormal tests results, and may also be referred to
other National Institutes of Health protocols.
- Additional tests will evaluate immune response to the measles, mumps, and rubella
(German measles) viruses. Some participants may be advised to have an additional MMR
vaccine through their primary care physician.
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| Study Summary: |
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Hepatitis B vaccine is very effective at preventing infection with the hepatitis B virus
(HBV). Several studies have reported on the long-term efficacy of the HBV vaccine and
indicate a decline in titers of antibody against hepatitis B surface antigen (anti-HBs) over
time. However, most of these studies were performed in persons vaccinated as infants or
children. This protocol is designed to examine the long-term immune status of HIV positive
and negative individuals who were vaccinated during adulthood, and to compare it to the
immune status of individuals who acquired natural immunity by recovering from acute
hepatitis B during adulthood. Individuals who lost the vaccine-induced humoral immune
response, will be offered a booster vaccination and their immune response to the booster
vaccination will be assessed. In this study, we will recruit 150 subjects who were
vaccinated secondary to their job-related risk of acquiring HBV infection. An additional 50
subjects who had spontaneously recovered from acute hepatitis B greater than or equal 10
years ago, 50 patients with well-compensated HIV infection who received HBV vaccine greater
than or equal to10 years ago and 10 subjects who were never vaccinated and never infected
with the hepatitis B virus will be enrolled as comparison groups. All subjects will be asked
to complete a questionnaire to assess their HBV exposure risk as well as factors that may
affect their immune response. Immunological assays include the quantitation of HBV-specific
antibodies and the qualitative and quantitative assessment of HBV-specific memory B cells
and T cells at the indicated time intervals after vaccination or after recovery from acute
hepatitis B. Additional immunological assays include testing for antibody to measles, mumps
and rubella (German measles) viruses to compare the longevity of antibody response to these
vaccines or natural infection to the antibody response to the hepatitis B vaccine or natural
infection. The results of this study will help to answer the question whether a booster
vaccination is required and at which time after the primary vaccination course it should be
considered.
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| Criteria: |
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- INCLUSION CRITERIA:
1. Age 18 years or above and < 60 years when the first dose of hepatitis B vaccine
was administered
2. Male or female
3. Vaccination with 3 doses of either plasma-derived or recombinant HBV vaccine
within one year (with the exception of the 10 patients who were never vaccinated
and never infected with the hepatitis B virus)
4. Vaccinated subjects must be able to provide written documentation indicating the
dates of their hepatitis B immunization series. In the absence of written
documentation, subjects will be asked to sign a written affidavit obtained
either from themselves or their physician stating the date of vaccination
accurate to one year and that they did not receive a booster dose to the best of
their knowledge.
5. For recovered patients, spontaneous recovery from acute hepatitis B must have
occurred prior to the year 2000
6. Willing and able to provide written, informed consent
Additional Inclusion Criteria for HIV positive cohort
1. CD4 count of great than or equal to 250 /mm3 at time of vaccination
2. Known HIV infection at time of vaccination
EXCLUSION CRITERIA:
1. History of chronic HBV infection
2. Incomplete HBV vaccine doses (with the exception of the 10 patients who were never
vaccinated and never infected with the hepatitis B virus)
3. Known non-response to an adequate course of hepatitis B vaccine
4. Received a booster dose of HBV vaccine
5. Current or recent (within the last 1 year) use of immunosuppressive/immuno-modifying
agents
6. Use of immunosuppressive/immuno-modifying agents at the time of vaccination
7. Renal failure with requirement for dialysis
8. Anti-HIV positive (Except for HIV positive cohort)
9. Anti-HCV positive
10. History of bone marrow or stem cell transplant
11. History of organ transplant
12. Known underlying immune suppressive condition
13. Subjects with clinically significant anemia, hemoglobin < 10g/dL will be excluded
from participating in the assessment of response to a booster dose of HBV vaccine
until their hemoglobin is greater than or equal to12g/dL.
14. Anti-HBc positivity for the 10 patients who were never vaccinated and never infected
with the hepatitis B virus.
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| NCT ID: |
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NCT01182311 |
| Primary Contact: |
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Principal Investigator
Marc G Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Elenita Rivera, R.N.
Phone: (301) 496-3531
Email: erivera@cc.nih.gov
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| Backup Contact: |
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Email: marcg@mail.nih.gov
Marc G Ghany, M.D.
Phone: (301) 402-5115
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| Location Contact: |
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Bethesda, Maryland 20892
United States
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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