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

NCT04193189 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 638

Last updated 2025-07-20

Study results available
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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

Interventions

BIOLOGICAL

HEPLISAV-B

Administered by IM injection

BIOLOGICAL

ENGERIX-B

Administered by IM injection

Sponsors & Collaborators

  • Dynavax Technologies Corporation

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Kenneth E. Sherman, MD, PhD · Cincinnati CRS

  • Kristen Marks, MD · Weill Cornell Chelsea CRS

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2024-08-13
Completion
2024-08-13
FDA Drug
Yes

Countries

  • United States
  • Botswana
  • Brazil
  • Kenya
  • Malawi
  • Philippines
  • South Africa
  • Thailand
  • Uganda
  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04193189 on ClinicalTrials.gov