At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 638 enrolled
Drug / intervention
HEPLISAV-B +1 morebiological
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.
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 10, 2019·Updated Jul 20, 2025
In Brief
A Phase 3 clinical trial evaluating HEPLISAV-B and ENGERIX-B for HIV Infection and Hepatitis B. Completed, enrolled 638 participants across 41 sites in 10 countries.
Detailed Summary
The purpose of this study was to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations of people living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infection, Hepatitis B
CountriesBotswana, Brazil, Kenya, Malawi, Philippines, South Africa, Thailand, Uganda, United States, Vietnam
CollaboratorsDynavax Technologies Corporation
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedDec 2019
Enrollment StartDec 2020
Primary CompletionAug 2024
TodayJul 2026
First PostedDec 10, 2019
Enrollment StartDec 14, 2020
Primary CompletionAug 13, 2024
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 6.6 years ago
Interventions
HEPLISAV-Bbiological
Administered by IM injection
ENGERIX-Bbiological
Administered by IM injection