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

HIV Infection Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

This phase III/IV study will evaluate the 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 (Group A) and individuals who are naïve to HBV vaccination (Group B). Group A (HBV vaccine non-responders) The study is designed as an open-label three-arm study to evaluate whether: 1. HEPLISAV-B vaccination given as a two-dose series achieves non-inferior seroprotection response (SPR) compared to standard dose ENGERIX-B. 2. HEPLISAV-B vaccination given as a three-dose series achieves superior SPR proportion compared to standard dose ENGERIX-B. Participants are randomized in 1:1:1 ratio to the following study arms, stratified by sex at birth (male vs. female) and diabetes diagnosis status (yes vs. no): - Arm 1: Two doses of HEPLISAV-B at weeks 0 and 4. - Arm 2: Three doses of HEPLISAV-B at weeks 0, 4, and 24. - Arm 3: Three doses of ENGERIX-B at weeks 0, 4, and 24. The target sample size in Group A is 561 participants, 187 participants in each arm. Group B (Naïve to HBV vaccination) Group B study is a single arm evaluation of vaccine response and safety of three doses of HEPLISAV-B. The target sample size is 73 participants. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04193189
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 14, 2020
Completion date July 26, 2024
View Details
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