Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

HIV Infection Hepatitis B

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

FieldValue
Enrollment Target 638 participants
Start Date 2020-12-14
Est. Completion 2024-08-13
Phase Phase 3

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04193189

The ClinicalTrials.gov registry entry for NCT04193189 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 638 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 234-participant average among 73 other HIV Infection trials with a reported enrollment target (173% higher). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

Learn More About Clinical Trials

Similar trials for HIV Infection

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

HIV Infection

All registered trials for this condition

Hepatitis B

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.