CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 205 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01182311
NCT01182311N/ACompleted

Duration of Long-Term Immunity After Hepatitis B Virus Immunization

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·observational·Posted Aug 16, 2010·Updated Dec 11, 2020

In Brief

An observational study for Hepatitis B. Completed, enrolled 205 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 16, 2010
Enrollment StartSep 8, 2010
Primary CompletionMay 1, 2013
Study CompletionDec 9, 2020
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.9 years ago