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NCT04193189 Clinical Trial

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

HIV Infection Clinical Trial

— BEe-HIVe  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04193189
Other study ID # ACTG A5379
Secondary ID 38569
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 14, 2020
Est. completion date July 26, 2024

Study information
Verified date May 2024
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders and individuals who are naïve to HBV vaccination.

Description:

This phase III/IV study will evaluate the response to and safety of the HBV vaccine HEPLISAV-B in two study populations living with HIV: prior HBV vaccine recipients who are deemed non-responders (Group A) and individuals who are naïve to HBV vaccination (Group B). Group A (HBV vaccine non-responders) The study is 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 proportion compared to standard dose ENGERIX-B. Participants are 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): - Arm 1: Two doses of HEPLISAV-B at weeks 0 and 4. - Arm 2: Three doses of HEPLISAV-B at weeks 0, 4, and 24. - Arm 3: Three doses of ENGERIX-B at weeks 0, 4, and 24. The target sample size in Group A is 561 participants, 187 participants in each arm. Group B (Naïve to HBV vaccination) Group B study is a single arm evaluation of vaccine response and safety of three doses of HEPLISAV-B. The target sample size is 73 participants. All participants will remain on their non-study-provided antiretroviral therapy (ART) throughout the study. Participants in both groups will attend several study visits through Week 72. Visits may include physical examinations and blood collection. For 7 days after each vaccination, participants will record temperature and any reactions they have to the vaccine.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 640
Est. completion date July 26, 2024
Est. primary completion date July 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 <1000 copies/mL Inclusion Criteria, Group A only - 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, 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• HEPLISAV-B
Administered by IM injection
• ENGERIX-B
Administered by IM injection

Locations
Country Name City State
Botswana Gaborone CRS Gaborone South-East District
Brazil Hospital Nossa Senhora da Conceicao CRS Porto Alegre Rio Grande Do Sul
Brazil Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS Rio De Janeiro
Haiti GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS Port-au-Prince
Haiti Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS Port-au-Prince
Kenya Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS Kericho Rift Valley
Malawi Blantyre CRS Blantyre
Philippines De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC) Cavite
South Africa Durban International Clinical Research Site CRS Durban Kwa Zulu Natal
South Africa Soweto ACTG CRS Johannesburg Soweto
South Africa Wits Helen Joseph Hospital CRS (Wits HJH CRS), Perth Road, Westdene Johannesburg Gauteng
Thailand Thai Red Cross AIDS Research Centre (TRC-ARC) CRS Bangkok
Thailand Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS Chiang Mai
Uganda Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site Kampala
United States The Ponce de Leon Center CRS Atlanta Georgia
United States University of Colorado Hospital CRS Aurora Colorado
United States Johns Hopkins University CRS Baltimore Maryland
United States Alabama CRS Birmingham Alabama
United States Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS Boston Massachusetts
United States Massachusetts General Hospital CRS (MGH CRS) Boston Massachusetts
United States Chapel Hill CRS Chapel Hill North Carolina
United States Northwestern University CRS Chicago Illinois
United States Rush University CRS Chicago Illinois
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 Trinity Health and Wellness Center CRS Dallas Texas
United States Greensboro CRS Greensboro North Carolina
United States Houston AIDS Research Team CRS Houston Texas
United States UCLA CARE Center CRS Los Angeles California
United States Venderbilt Therapeutics (VT) CRS Nashville Tennessee
United States Columbia P&S CRS New York New York
United States Weill Cornell Chelsea CRS New York New York
United States Weill Cornell Uptown CRS New York New York
United States New Jersey Medical School Clinical Research Center CRS Newark New Jersey
United States Penn Therapeutics CRS Philadelphia Pennsylvania
United States University of Pittsburgh CRS Pittsburgh Pennsylvania
United States University of Rochester Adult HIV Therapeutic Strategies Network CRS Rochester New York
United States Washington University Therapeutics (WT) CRS Saint Louis Missouri
United States UCSD Antiviral Research Center San Diego California
United States Ucsf Hiv/Aids Crs San Francisco California
United States University of Washington AIDS CRS Seattle Washington
United States Harbor-UCLA CRS Torrance California
United States Whitman-Walker Health CRS Washington District of Columbia
Vietnam Hanoi Medical University CRS Ð?ng Ða Hanoi

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) Dynavax Technologies Corporation

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Seroprotection response defined as hepatitis B virus surface antibody (HBsAb) =10 mIU/mL Week 12 in Group A, Arm 1, Week 28 in Group A, Arms 2 and 3 and in Group B
Primary Occurrence of Adverse events (AEs) DAIDS AE Grading Table (Version 2.1) will be used. From vaccination initiation to study discontinuation (Week 72 or premature discontinuation)
Secondary Seroprotection response defined as HBsAb =10 mIU/mL Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Secondary HBsAb titer Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Secondary Occurrence of Grade =2 AEs within 4 weeks after each injection From vaccination initiation to Week 28
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