B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
NCT ID: NCT04193189
Last Updated: 2025-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
638 participants
INTERVENTIONAL
2020-12-14
2024-08-13
Brief Summary
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Detailed Description
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Group A (HBV vaccine non-responders)
The study was 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 compared to standard dose ENGERIX-B.
Participants were 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):
2-CpG: Two doses of HEPLISAV-B at weeks 0 and 4.
3-CpG: Three doses of HEPLISAV-B at weeks 0, 4, and 24.
3-alum: Three doses of ENGERIX-B at weeks 0, 4, and 24.
The target sample size in Group A was 561 participants, 187 participants in each arm.
Group B (Naïve to HBV vaccination)
Group B study was a single arm evaluation of vaccine response and safety of three doses of HEPLISAV-B. The target sample size was 73 participants.
In both groups, participants were scheduled to attend several study visits through Week 72. All participants were to remain on their antiretroviral therapy (ART), not provided by the study, throughout the study. Visits included physical examinations and blood collection. For 7 days after each vaccination, participants were asked to record temperature and any reactions they experienced.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group A, 2-CpG: HEPLISAV-B (two injections)
Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by intramuscular (IM) injection at Weeks 0 and 4.
HEPLISAV-B
Administered by IM injection
Group A, 3-CpG: HEPLISAV-B (three injections)
Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by IM injection at Weeks 0, 4, and 24.
HEPLISAV-B
Administered by IM injection
Group A, 3-alum: ENGERIX-B (three injections)
Participants were prescribed 1 mL of ENGERIX-B (conventional hepatitis B vaccine with an aluminum hydroxide adjuvant) by IM injection at Weeks 0, 4, and 24.
ENGERIX-B
Administered by IM injection
Group B: HEPLISAV-B (three injections)
Participants were prescribed 0.5 mL of HEPLISAV-B (hepatitis B vaccine with a cytosine phosphoguanine adjuvant) by IM injection at Weeks 0, 4, and 24.
HEPLISAV-B
Administered by IM injection
Interventions
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HEPLISAV-B
Administered by IM injection
ENGERIX-B
Administered by IM injection
Eligibility Criteria
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Inclusion Criteria
* On current HIV-1 antiretroviral therapy (ART)
* CD4+ T-cell count ≥100 cells/mm\^3
* HIV-1 RNA \<1000 copies/mL
* Serum Hepatitis B antibody \<10 mlU/mL, non-reactive (negative), or indeterminate
* Documentation of HBV vaccination \>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
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Dynavax Technologies Corporation
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Kenneth E. Sherman, MD, PhD
Role: STUDY_CHAIR
Cincinnati CRS
Kristen Marks, MD
Role: STUDY_CHAIR
Weill Cornell Chelsea CRS
Locations
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Alabama CRS
Birmingham, Alabama, United States
UCLA CARE Center CRS
Los Angeles, California, United States
UCSD Antiviral Research Center
San Diego, California, United States
Ucsf Hiv/Aids Crs
San Francisco, California, United States
Harbor-UCLA CRS
Torrance, California, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Whitman-Walker Health CRS
Washington D.C., District of Columbia, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
Northwestern University CRS
Chicago, Illinois, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
Boston, Massachusetts, United States
Washington University Therapeutics (WT) CRS
St 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
Weill Cornell Uptown CRS
New York, New York, United States
University of Rochester Adult HIV Therapeutic Strategies Network CRS
Rochester, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Greensboro CRS
Greensboro, North Carolina, United States
Cincinnati Clinical Research Site
Cincinnati, Ohio, United States
Case Clinical Research Site
Cleveland, Ohio, United States
Ohio State University CRS
Columbus, Ohio, United States
Penn Therapeutics CRS
Philadelphia, Pennsylvania, United States
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States
Vanderbilt Therapeutics (VT) CRS
Nashville, Tennessee, United States
Houston AIDS Research Team CRS
Houston, Texas, United States
University of Washington AIDS CRS
Seattle, Washington, 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
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
Kericho, Rift Valley, Kenya
Blantyre CRS
Blantyre, , Malawi
De La Salle Health Science Institute Angelo King Medical Research Center
Silang, , Philippines
Wits Helen Joseph Hospital CRS (Wits HJH CRS), Perth Road, Westdene
Johannesburg, Gauteng, South Africa
Durban International Clinical Research Site CRS
Durban, KwaZulu-Natal, South Africa
Soweto ACTG CRS
Johannesburg, Soweto, South Africa
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Bangkok, , Thailand
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
Chiang Mai, , Thailand
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
Kampala, , Uganda
Hanoi Medical University CRS
Đống Đa, Hanoi, Vietnam
Countries
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References
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Marks KM, Kang M, Umbleja T, Avihingsanon A, Sugandhavesa P, Cox AL, Vigil K, Perazzo H, Price JC, Katsidzira L, Vernon C, Alston-Smith B, Sherman KE; ACTG 5379 Study Team. Immunogenicity and Safety of Hepatitis B Virus (HBV) Vaccine With a Toll-Like Receptor 9 Agonist Adjuvant in HBV Vaccine-Naive People With Human Immunodeficiency Virus. Clin Infect Dis. 2023 Aug 14;77(3):414-418. doi: 10.1093/cid/ciad201.
Marks KM, Kang M, Umbleja T, Cox A, Vigil KJ, Ta NT, Omoz-Oarhe A, Perazzo H, Kosgei J, Hatlen T, Price J, Katsidzira L, Supparatpinyo K, Knowles K, Alston-Smith BL, Rathod P, Sherman KE; ACTG 5379 (BEe-HIVe) Study Team. HepB-CpG vs HepB-Alum Vaccine in People With HIV and Prior Vaccine Nonresponse: The BEe-HIVe Randomized Clinical Trial. JAMA. 2025 Jan 28;333(4):295-306. doi: 10.1001/jama.2024.24490.
Kang M, Marks KM, Cox AL, Sherman KE. An efficient vaccine clinical trial: ACTG A5379 hepatitis B vaccine trial in persons with HIV. Vaccine. 2025 May 10;55:127028. doi: 10.1016/j.vaccine.2025.127028. Epub 2025 Mar 26.
Provided Documents
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Document Type: Study Protocol and Informed Consent Form: V3.0
Document Type: Study Protocol: Clarification Memo V3.0
Document Type: Study Protocol: Letter of Amendment V2.0
Document Type: Statistical Analysis Plan
Related Links
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Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017
Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010
Other Identifiers
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38569
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG A5379
Identifier Type: -
Identifier Source: org_study_id
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