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
• 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
• 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

Related Conditions & MeSH terms

• Hepatitis B
• HIV Infection

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