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.

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.

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

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.

72 weeks