NCT01182311

Duration of Long-term Immunity After Hepatitis B Virus Immunization

Completed Last updated 11 December 2020

What this trial tests

trial in Hepatitis B in 205 participants. Completed in 9 December 2020.

Timeline

8 September 2010

Primary endpoint
1 May 2013

9 December 2020

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	205
Start date	8 September 2010
Primary completion	1 May 2013
Estimated completion	9 December 2020
Sites	1 location across United States

Conditions studied

• Hepatitis B — all drugs for Hepatitis B →

Sponsor

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

Who can join

18 and older, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Durability of antibody response against hepatitis B virus in healthcare workers vaccinated as adults.
   Gara N, Abdalla A, Rivera E, Zhao X, et al · · 2015 · cited 55× · PMID 25389254 · DOI 10.1093/cid/ciu867
2. The hepatitis B vaccine protects re-exposed health care workers, but does not provide sterilizing immunity.
   Werner JM, Abdalla A, Gara N, Ghany MG, et al · · 2013 · cited 46× · PMID 23916846 · DOI 10.1053/j.gastro.2013.07.044