A5379: B-Enhancement of HBV vaccination in persons living with HIV (BEe-HIVe): Evaluation of HEPLISAV-B
A5379 is a study looking at hepatitis B vaccination in adults living with HIV. Hepatitis B is a serious viral infection that affects the liver and is transmitted through blood and body fluids. The study will involve individuals who have received a previous hepatitis B vaccination but the vaccine did not respond well and individuals who have never received the vaccination. The study will take place both in the US and internationally. The study will compare how well an individual responds to the vaccine in different groups based on the type of vaccine and number of doses.
Purpose of the Study: Vaccination for hepatitis B in individuals living with HIV does not always work, especially in those with impaired immune systems or ability to fight infection. Prevention of hepatitis B in individuals living with HIV has primarily been done by vaccinating with a series of 3 shots given over 6 months. A new vaccine, called HEPLISAV-B, has been approved that may provide a better response than what has currently been used. The researchers will study whether this vaccine will prove to be more effective than the current standard.
Requirements to Enter Study:
Living with HIV
Been on HIV treatment for more than 56 days
Previously received vaccines for hepatitis B, but the vaccines didn’t work
There will be a small group of participants (73) who have never been vaccinated for hepatitis B.
CD4 cell count (the number of white blood cells that fight infection) more than 100
HIV viral load (how much HIV is in the body) less than 1000
In the group vaccinated with a hepatitis B vaccine, the vaccination was over 168 days ago
Exclusion: No previous hepatitis B infection or exposure to hepatitis B infection
Treatment: HEPLISAV-B vaccine given at entry and at 4 weeks or
HEPLISAV-B vaccine given at entry, 4 weeks and 24 weeks or
Engerix-B vaccine given at entry, 4 weeks and 24 weeks.
Duration: 72 weeks