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

Primary Purpose

HIV Infection, Hepatitis B

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HEPLISAV-B
ENGERIX-B
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama CRS
  • UCLA CARE Center CRS
  • UCSD Antiviral Research Center
  • Ucsf Hiv/Aids Crs
  • Harbor-UCLA CRS
  • University of Colorado Hospital CRS
  • Whitman-Walker Health CRS
  • The Ponce de Leon Center CRS
  • Northwestern University CRS
  • Rush University CRS
  • Johns Hopkins University CRS
  • Massachusetts General Hospital CRS (MGH CRS)
  • Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
  • Washington University Therapeutics (WT) CRS
  • New Jersey Medical School Clinical Research Center CRS
  • Weill Cornell Chelsea CRS
  • Columbia P&S CRS
  • Weill Cornell Uptown CRS
  • University of Rochester Adult HIV Therapeutic Strategies Network CRS
  • Chapel Hill CRS
  • Greensboro CRS
  • Cincinnati Clinical Research Site
  • Case Clinical Research Site
  • Ohio State University CRS
  • Penn Therapeutics CRS
  • University of Pittsburgh CRS
  • Venderbilt Therapeutics (VT) CRS
  • Trinity Health and Wellness Center CRS
  • Houston AIDS Research Team CRS
  • University of Washington AIDS CRS
  • Gaborone CRS
  • Hospital Nossa Senhora da Conceicao CRS
  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
  • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
  • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
  • Chennai Antiviral Research and Treatment (CART) CRS
  • Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
  • Blantyre CRS
  • De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC)
  • Wits Helen Joseph Hospital CRS (Wits HJH CRS), Perth Road, Westdene
  • Durban International Clinical Research Site CRS
  • Soweto ACTG CRS
  • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
  • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
  • Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
  • Hanoi Medical University CRS

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A, Arm 1: HEPLISAV-B (two injections)

Group A, Arm 2: HEPLISAV-B (three injections)

Group A, Arm 3: ENGERIX-B (three injections)

Group B: HEPLISAV-B (three injections)

Arm Description

Participants will receive 0.5 mL of HEPLISAV-B by intramuscular (IM) injection at Weeks 0 and 4.

Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.

Participants will receive 1 mL of ENGERIX-B by IM injection at Weeks 0, 4, and 24.

Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.

Outcomes

Primary Outcome Measures

Seroprotection response defined as hepatitis B virus surface antibody (HBsAb) ≥10 mIU/mL
Occurrence of Adverse events (AEs)
DAIDS AE Grading Table (Version 2.1) will be used.

Secondary Outcome Measures

Seroprotection response defined as HBsAb ≥10 mIU/mL
HBsAb titer
Occurrence of Grade ≥2 AEs within 4 weeks after each injection

Full Information

First Posted
December 6, 2019
Last Updated
September 5, 2023
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04193189
Brief Title
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
Acronym
BEe-HIVe
Official Title
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Dynavax Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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: HEPLISAV-B vaccination given as a two-dose series achieves non-inferior seroprotection response (SPR) compared to standard dose ENGERIX-B. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Hepatitis B

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A, Arm 1: HEPLISAV-B (two injections)
Arm Type
Experimental
Arm Description
Participants will receive 0.5 mL of HEPLISAV-B by intramuscular (IM) injection at Weeks 0 and 4.
Arm Title
Group A, Arm 2: HEPLISAV-B (three injections)
Arm Type
Experimental
Arm Description
Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.
Arm Title
Group A, Arm 3: ENGERIX-B (three injections)
Arm Type
Experimental
Arm Description
Participants will receive 1 mL of ENGERIX-B by IM injection at Weeks 0, 4, and 24.
Arm Title
Group B: HEPLISAV-B (three injections)
Arm Type
Experimental
Arm Description
Participants will receive 0.5 mL of HEPLISAV-B by IM injection at Weeks 0, 4, and 24.
Intervention Type
Biological
Intervention Name(s)
HEPLISAV-B
Intervention Description
Administered by IM injection
Intervention Type
Biological
Intervention Name(s)
ENGERIX-B
Intervention Description
Administered by IM injection
Primary Outcome Measure Information:
Title
Seroprotection response defined as hepatitis B virus surface antibody (HBsAb) ≥10 mIU/mL
Time Frame
Week 12 in Group A, Arm 1, Week 28 in Group A, Arms 2 and 3 and in Group B
Title
Occurrence of Adverse events (AEs)
Description
DAIDS AE Grading Table (Version 2.1) will be used.
Time Frame
From vaccination initiation to study discontinuation (Week 72 or premature discontinuation)
Secondary Outcome Measure Information:
Title
Seroprotection response defined as HBsAb ≥10 mIU/mL
Time Frame
Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Title
HBsAb titer
Time Frame
Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72
Title
Occurrence of Grade ≥2 AEs within 4 weeks after each injection
Time Frame
From vaccination initiation to Week 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 <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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth E. Sherman, MD, PhD
Organizational Affiliation
Cincinnati CRS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristen Marks, MD
Organizational Affiliation
Weill Cornell Chelsea CRS
Official's Role
Study Chair
Facility Information:
Facility Name
Alabama CRS
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35222
Country
United States
Facility Name
UCLA CARE Center CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035-4709
Country
United States
Facility Name
UCSD Antiviral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ucsf Hiv/Aids Crs
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Harbor-UCLA CRS
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado Hospital CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Whitman-Walker Health CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20005
Country
United States
Facility Name
The Ponce de Leon Center CRS
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308-2012
Country
United States
Facility Name
Northwestern University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Johns Hopkins University CRS
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital CRS (MGH CRS)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Washington University Therapeutics (WT) CRS
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1010
Country
United States
Facility Name
New Jersey Medical School Clinical Research Center CRS
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Weill Cornell Chelsea CRS
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Name
Columbia P&S CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Uptown CRS
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Adult HIV Therapeutic Strategies Network CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Chapel Hill CRS
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Greensboro CRS
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Cincinnati Clinical Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Case Clinical Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University CRS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn Therapeutics CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh CRS
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Venderbilt Therapeutics (VT) CRS
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
47183
Country
United States
Facility Name
Trinity Health and Wellness Center CRS
City
Dallas
State/Province
Texas
ZIP/Postal Code
75208
Country
United States
Facility Name
Houston AIDS Research Team CRS
City
Houston
State/Province
Texas
ZIP/Postal Code
77009
Country
United States
Facility Name
University of Washington AIDS CRS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104-9929
Country
United States
Facility Name
Gaborone CRS
City
Gaborone
State/Province
South-East District
Country
Botswana
Facility Name
Hospital Nossa Senhora da Conceicao CRS
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350
Country
Brazil
Facility Name
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
City
Rio De Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
Facility Name
GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS
City
Port-au-Prince
ZIP/Postal Code
HT-6110
Country
Haiti
Facility Name
Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
City
Port-au-Prince
ZIP/Postal Code
HT-6110
Country
Haiti
Facility Name
Chennai Antiviral Research and Treatment (CART) CRS
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600113
Country
India
Facility Name
Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS
City
Kericho
State/Province
Rift Valley
ZIP/Postal Code
20200
Country
Kenya
Facility Name
Blantyre CRS
City
Blantyre
Country
Malawi
Facility Name
De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC)
City
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Wits Helen Joseph Hospital CRS (Wits HJH CRS), Perth Road, Westdene
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2092
Country
South Africa
Facility Name
Durban International Clinical Research Site CRS
City
Durban
State/Province
Kwa Zulu Natal
ZIP/Postal Code
4052
Country
South Africa
Facility Name
Soweto ACTG CRS
City
Johannesburg
State/Province
Soweto
ZIP/Postal Code
1862
Country
South Africa
Facility Name
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site
City
Kampala
ZIP/Postal Code
10005
Country
Uganda
Facility Name
Hanoi Medical University CRS
City
Đống Đa
State/Province
Hanoi
ZIP/Postal Code
10000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie results in the publication, after deidentification.
IPD Sharing Time Frame
Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
IPD Sharing Access Criteria
With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the AIDS Clinical Trials Group. For what types of analyses? To achieve aims in the proposal approved by the AIDS Clinical Trials Group. By what mechanism will data be made available? Researchers may submit a request for access to data using the AIDS Clinical Trials Group "Data Request" form at: https://submit.mis.s-3.net/ Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.

Learn more about this trial

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

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