Duration of Long-term Immunity After Hepatitis B Virus Immunization

Completed

Conditions studied: Hepatitis B

In brief

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.

Key facts

Study ID: NCT01182311
Run by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
People needed: 205
Starts: 2010-09-08
Expected to finish: 2020-12-09
Last updated by the study team: 2020-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

History of chronic HBV infection
Incomplete HBV vaccine doses (with the exception of the 10 patients who were never vaccinated and never infected with the hepatitis B virus)
Known non-response to an adequate course of hepatitis B vaccine
Received a booster dose of HBV vaccine
Current or recent (within the last 1 year) use of immunosuppressive/immuno-modifying agents
Use of immunosuppressive/immuno-modifying agents at the time of vaccination
Renal failure with requirement for dialysis
Anti-HIV positive (Except for HIV positive cohort)
Anti-HCV positive
History of bone marrow or stem cell transplant
History of organ transplant
Known underlying immune suppressive condition
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.
Anti-HBc positivity for the 10 patients who were never vaccinated and never infected with the hepatitis B virus.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.