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NCT04193189 · ClinicalTrials.gov registry record · Phase 3
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
A Phase 3 study of HIV Infection and Hepatitis B, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 638
- Enrollment target
- 20
- Study locations
NCT04193189: Completed Phase 3 study of HIV Infection and Hepatitis B, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04193189 is a Phase 3 study of HIV Infection and Hepatitis B that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 638 participants, above the 234-participant average among 73 other HIV Infection trials with a reported enrollment target (173% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04193189, a Phase 3 study of HIV Infection and Hepatitis B, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 638 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Primary seroprotection response was defined as antibody titer against hepatitis B surface antigen (anti-HBs) ≥10 mIU/mL at 8 weeks after 2-dose vaccination series and at 4 weeks after 3-dose vaccination series. If the completion of the vaccine series was delayed (a delay of ≤4 weeks was allowed), the trial protocol specified obtaining an antibody result at 8 weeks for the 2-dose series or at 4 weeks for the 3-dose series after vaccine completion for use in the primary outcome analysis. The study
Conditions Studied
Interventions
- BIOLOGICAL HEPLISAV-B
- BIOLOGICAL ENGERIX-B
Study Locations (20)
California
- UCLA CARE Center CRS - Los Angeles
- UCSD Antiviral Research Center - San Diego
- Ucsf Hiv/Aids Crs - San Francisco
- Harbor-UCLA CRS - Torrance
New York
- Weill Cornell Chelsea CRS - New York
- Columbia P&S CRS - New York
- Weill Cornell Uptown CRS - New York
- University of Rochester Adult HIV Therapeutic Strategies Network CRS - Rochester
Massachusetts
- Massachusetts General Hospital CRS (MGH CRS) - Boston
- Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS - Boston
North Carolina
- Chapel Hill CRS - Chapel Hill
- Greensboro CRS - Greensboro
Alabama
- Alabama CRS - Birmingham
Colorado
- University of Colorado Hospital CRS - Aurora
District of Columbia
- Whitman-Walker Health CRS - Washington D.C.
Georgia
- The Ponce de Leon Center CRS - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 638 participants |
| Start Date | 2020-12-14 |
| Est. Completion | 2024-08-13 |
| Phase | Phase 3 |
What the finished NCT04193189 record still lists
NCT04193189 is an interventional study that assigns participants to a tested intervention. The registered 638 participants enrollment target is mid-sized for trials with a published cap, above the 234-participant average among 73 other HIV Infection trials with a reported enrollment target (173% higher).
The record links to 2 conditions, with HIV Infection appearing as the primary indexed condition, and to 2 interventions - of which HEPLISAV-B is the first listed.
NCT04193189 names 20 study sites across 12 states, led by California, New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04193189 about?
NCT04193189 is a clinical study titled "B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B". 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.
What is the current status of trial NCT04193189?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 638 participants. The study started on 2020-12-14. Estimated completion is 2024-08-13.
What conditions does trial NCT04193189 study?
This clinical trial studies the following conditions: HIV Infection, Hepatitis B.
What interventions are being tested in trial NCT04193189?
The interventions under investigation include: HEPLISAV-B (BIOLOGICAL), ENGERIX-B (BIOLOGICAL).
Who is sponsoring clinical trial NCT04193189?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04193189 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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