B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B

The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination. All participants will remain on their non-study-provided antiretroviral therapy (ART) throughout the study. Participants in both groups will attend several study visits through Week 72. Visits may include physical examinations and blood collection. For 7 days after each vaccination, participants will record temperature and any reactions they have to the vaccine.

DURATION: December 2020 - Ongoing

STUDY TYPE: HIV & Comorbidities

PHASE: 3

DESIGN: Randomized, parallel assigned, open-label, interventional study

STATUS: Ongoing

ENROLLMENT: ≈ 634

POPULATION: People living with HIV,  18 to 70 years old

NUMBER OF SITES: 48

SITE LOCATIONS: US, Botswana, Brazil, Haiti, India, Kenya, Malawi, Philippines, South Africa, Thailand, Uganda, Vietnam, Zimbabwe

NCT #: NCT04193189

RESULTS