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Protocol Details

Duration of Long-Term Immunity After Hepatitis B Virus Immunization

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: N/A

Referral Letter Required


Population Exclusion(s)


Special Instructions

Currently Not Provided


Hepatitis B Virus;
Hepatitis B Vaccine;
B-Cell Response;
T-Cell Response

Recruitment Keyword(s)

Hepatitis B Immunity;
Hepatitis B Virus Vaccine


Hepatitis B

Investigational Drug(s)


Investigational Device(s)




Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases


- 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.


- 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.


- 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.


- 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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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


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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Dienstag JL. Hepatitis B virus infection. N Engl J Med. 2008 Oct 2;359(14):1486-500. Review. Erratum in: N Engl J Med. 2010 Jul 15;363(3):298.

Kim WR. Epidemiology of hepatitis B in the United States. Hepatology. 2009 May;49(5 Suppl):S28-34.

McQuillan GM, Coleman PJ, Kruszon-Moran D, Moyer LA, Lambert SB, Margolis HS. Prevalence of hepatitis B virus infection in the United States: the National Health and Nutrition Examination Surveys, 1976 through 1994. Am J Public Health. 1999 Jan;89(1):14-8.

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Principal Investigator

Referral Contact

For more information:

Marc G. Ghany, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
BG 10 RM 10N248D
(301) 402-5115

Elenita Rivera, R.N.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 8E
10 Center Drive
Bethesda, Maryland 20892
(301) 435-6125

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010

Clinical Trials Number:


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