B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
- Conditions
- HIV InfectionHepatitis B
- Interventions
- Registration Number
- NCT04193189
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 640
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A, Arm 1: HEPLISAV-B (two injections) HEPLISAV-B Participants will receive 0.5 mL of HEPLISAV-B by intramuscular (IM) injection at Weeks 0 and 4. Group A, Arm 2: HEPLISAV-B (three injections) HEPLISAV-B Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24. Group B: HEPLISAV-B (three injections) HEPLISAV-B Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24. Group A, Arm 3: ENGERIX-B (three injections) ENGERIX-B Participants will receive 1 mL of ENGERIX-B by IM injection at Weeks 0, 4, and 24.
- Primary Outcome Measures
Name Time Method Occurrence of Adverse events (AEs) From vaccination initiation to study discontinuation (Week 72 or premature discontinuation) DAIDS AE Grading Table (Version 2.1) will be used.
Seroprotection response defined as hepatitis B virus surface antibody (HBsAb) ≥10 mIU/mL Week 12 in Group A, Arm 1, Week 28 in Group A, Arms 2 and 3 and in Group B
- Secondary Outcome Measures
Name Time Method HBsAb titer Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72 Occurrence of Grade ≥2 AEs within 4 weeks after each injection From vaccination initiation to Week 28 Seroprotection response defined as HBsAb ≥10 mIU/mL Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Trial Locations
- Locations (45)
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Rush University CRS
🇺🇸Chicago, Illinois, United States
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
🇺🇸Boston, Massachusetts, United States
Houston AIDS Research Team CRS
🇺🇸Houston, Texas, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
UCSD Antiviral Research Center
🇺🇸San Diego, California, United States
Alabama CRS
🇺🇸Birmingham, Alabama, United States
Harbor-UCLA CRS
🇺🇸Torrance, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Whitman-Walker Health CRS
🇺🇸Washington, District of Columbia, United States
The Ponce de Leon Center CRS
🇺🇸Atlanta, Georgia, United States
Johns Hopkins University CRS
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospital CRS (MGH CRS)
🇺🇸Boston, Massachusetts, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Washington University Therapeutics (WT) CRS
🇺🇸Saint Louis, Missouri, United States
New Jersey Medical School Clinical Research Center CRS
🇺🇸Newark, New Jersey, United States
Weill Cornell Chelsea CRS
🇺🇸New York, New York, United States
Columbia P&S CRS
🇺🇸New York, New York, United States
Chapel Hill CRS
🇺🇸Chapel Hill, North Carolina, United States
Weill Cornell Uptown CRS
🇺🇸New York, New York, United States
University of Rochester Adult HIV Therapeutic Strategies Network CRS
🇺🇸Rochester, New York, United States
Greensboro CRS
🇺🇸Greensboro, North Carolina, United States
Cincinnati Clinical Research Site
🇺🇸Cincinnati, Ohio, United States
Ohio State University CRS
🇺🇸Columbus, Ohio, United States
Case Clinical Research Site
🇺🇸Cleveland, Ohio, United States
Penn Therapeutics CRS
🇺🇸Philadelphia, Pennsylvania, United States
Trinity Health and Wellness Center CRS
🇺🇸Dallas, Texas, United States
University of Pittsburgh CRS
🇺🇸Pittsburgh, Pennsylvania, United States
Gaborone CRS
🇧🇼Gaborone, South-East District, Botswana
Hospital Nossa Senhora da Conceicao CRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
🇧🇷Rio De Janeiro, Brazil
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
🇭🇹Port-au-Prince, Haiti
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
🇰🇪Kericho, Rift Valley, Kenya
De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC)
🇵🇭Cavite, Philippines
Blantyre CRS
🇲🇼Blantyre, Malawi
Wits Helen Joseph Hospital CRS (Wits HJH CRS), Perth Road, Westdene
🇿🇦Johannesburg, Gauteng, South Africa
Soweto ACTG CRS
🇿🇦Johannesburg, Soweto, South Africa
Durban International Clinical Research Site CRS
🇿🇦Durban, Kwa Zulu Natal, South Africa
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
🇹🇭Chiang Mai, Thailand
Hanoi Medical University CRS
🇻🇳Đống Đa, Hanoi, Vietnam
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
🇺🇬Kampala, Uganda
Ucsf Hiv/Aids Crs
🇺🇸San Francisco, California, United States
Venderbilt Therapeutics (VT) CRS
🇺🇸Nashville, Tennessee, United States
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
🇭🇹Port-au-Prince, Haiti
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
🇹🇭Bangkok, Thailand