Phase 3
N=638
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
HIV Infection · Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT04193189 ↗Enrolled (actual)
638
Serious AEs
6.6%
Results posted
Jul 2025
Primary outcome: Primary: Percentage of Participants With Primary Seroprotection Response — 93.1; 99.4; 80.6; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HEPLISAV-B (Biological); ENGERIX-B (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Primary Seroprotection Response |
93.1; 99.4; 80.6; 100 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) |
73.3; 77.7; 73.7; 87.8 | — |
| SECONDARY Percentage of Participants With Seroprotection Response |
66.1; 66.7; 51.7; 30.1; 89.1; 90.8 | — |
| SECONDARY Count of Participants by Anti-HBs Titer Categories |
47; 52; 80; 46; 13; 7 | — |
| SECONDARY Percentage of Participants With Grade ≥2 AEs Post-vaccination Adverse Events |
33.7; 45.7; 43.5; 48.6 | — |
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.
Eligibility Criteria
Inclusion Criteria, Groups A and B
- HIV-1 infection
- On current HIV-1 antiretroviral therapy (ART)
- CD4+ T-cell count ≥100 cells/mm^3
- HIV-1 RNA 168 days prior to study entry
Inclusion Criterion, Group B only
- Serum Hepatitis B antibody non-reactive (negative) within 45 days prior to study entry
Exclusion Criteria, Groups A and B
- Infection or prior exposure to HBV
- Serum HBsAb level ≥10 mlU/mL or positive at screening or any other time prior to screening
- Presence of any active or acute AIDS-defining opportunistic infections
- Solid organ transplantation
- History of ascites, encephalopathy, or variceal hemorrhage
- Diagnosis of chronic kidney disease (CKD) stage G4
- Cancer diagnosis within 5 years
- Currently receiving chemotherapy
- Chronic use and/or receipt of systemically administered immunosuppressive
- Known allergy/sensitivity or any hypersensitivity to any HBV vaccine or yeast
- Active, serious infection other than HIV-1
- Receipt of any inactivated virus vaccine within 14 days
- Receipt of any of the following within 45 days prior to study entry:
- Live virus vaccine
- Granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Any other investigational medicinal agent
- Receipt of immunoglobulin or blood products within 90 days prior to study entry
- Receipt of an injection of DNA plasmids or oligonucleotides within 60 days prior to study entry
Exclusion Criteria, Group A only
- Hepatitis B virus vaccination ≤168 days prior to study entry
- Receipt of HEPLISAV-B vaccine at any time prior to study entry
Exclusion Criterion, Group B only
- Known HBV vaccination prior to study entry
Data sourced from ClinicalTrials.gov (NCT04193189). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.