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

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Recruiting
CT.gov ID
NCT04193189
Collaborator
Dynavax Technologies Corporation (Industry)
634
Enrollment
46
Locations
4
Arms
27.2
Anticipated Duration (Months)
13.8
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: HEPLISAV-B
  • Biological: ENGERIX-B
 Phase 3

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:

  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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
634 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
Actual Study Start Date :
Dec 14, 2020
Anticipated Primary Completion Date :
Mar 22, 2023
Anticipated Study Completion Date :
Mar 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A, Arm 1: HEPLISAV-B (two injections)

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

Biological: HEPLISAV-B
Administered by IM injection
Experimental: Group A, Arm 2: HEPLISAV-B (three injections)

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

Biological: HEPLISAV-B
Administered by IM injection
Experimental: Group A, Arm 3: ENGERIX-B (three injections)

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

Biological: ENGERIX-B
Administered by IM injection
Experimental: Group B: HEPLISAV-B (three injections)

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

Biological: HEPLISAV-B
Administered by IM injection

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Occurrence of Adverse events (AEs) [From vaccination initiation to study discontinuation (Week 72 or premature discontinuation)]

    DAIDS AE Grading Table (Version 2.1) will be used.

Secondary Outcome Measures

  1. Seroprotection response defined as HBsAb ≥10 mIU/mL [Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72]

  2. HBsAb titer [Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72]

  3. Occurrence of Grade ≥2 AEs within 4 weeks after each injection [From vaccination initiation to Week 28]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alabama CRS Birmingham Alabama United States 35222
2 UCLA CARE Center CRS Los Angeles California United States 90035-4709
3 UCSD Antiviral Research Center San Diego California United States 92103
4 Ucsf Hiv/Aids Crs San Francisco California United States 94110
5 Harbor-UCLA CRS Torrance California United States 90502
6 University of Colorado Hospital CRS Aurora Colorado United States 80045
7 Whitman-Walker Health CRS Washington District of Columbia United States 20005
8 The Ponce de Leon Center CRS Atlanta Georgia United States 30308-2012
9 Northwestern University CRS Chicago Illinois United States 60611
10 Rush University CRS Chicago Illinois United States 60612
11 Johns Hopkins University CRS Baltimore Maryland United States 21287
12 Massachusetts General Hospital CRS (MGH CRS) Boston Massachusetts United States 02114
13 Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS Boston Massachusetts United States 02115
14 Washington University Therapeutics (WT) CRS Saint Louis Missouri United States 63110-1010
15 New Jersey Medical School Clinical Research Center CRS Newark New Jersey United States 07103
16 Weill Cornell Chelsea CRS New York New York United States 10010
17 Columbia P&S CRS New York New York United States 10032
18 Weill Cornell Uptown CRS New York New York United States 10065
19 University of Rochester Adult HIV Therapeutic Strategies Network CRS Rochester New York United States 14642
20 Chapel Hill CRS Chapel Hill North Carolina United States 27599
21 Greensboro CRS Greensboro North Carolina United States 27401
22 Cincinnati Clinical Research Site Cincinnati Ohio United States 45219
23 Case Clinical Research Site Cleveland Ohio United States 44106
24 Ohio State University CRS Columbus Ohio United States 43210
25 Penn Therapeutics CRS Philadelphia Pennsylvania United States 19104
26 University of Pittsburgh CRS Pittsburgh Pennsylvania United States 15213
27 Venderbilt Therapeutics (VT) CRS Nashville Tennessee United States 47183
28 Trinity Health and Wellness Center CRS Dallas Texas United States 75208
29 Houston AIDS Research Team CRS Houston Texas United States 77009
30 University of Washington AIDS CRS Seattle Washington United States 98104-9929
31 Gaborone CRS Gaborone South-East District Botswana
32 Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS Rio De Janeiro Brazil 21040-360
33 GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS Port-au-Prince Haiti HT-6110
34 Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS Port-au-Prince Haiti HT-6110
35 Chennai Antiviral Research and Treatment (CART) CRS Chennai Tamil Nadu India 600113
36 Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS Kericho Rift Valley Kenya 20200
37 Blantyre CRS Blantyre Malawi
38 De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC) Cavite Philippines 4114
39 Wits Helen Joseph Hospital CRS (Wits HJH CRS), Perth Road, Westdene Johannesburg Gauteng South Africa 2092
40 Durban International Clinical Research Site CRS Durban Kwa Zulu Natal South Africa 4052
41 Soweto ACTG CRS Johannesburg Soweto South Africa 1862
42 Thai Red Cross AIDS Research Centre (TRC-ARC) CRS Bangkok Thailand 10330
43 Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS Chiang Mai Thailand 50200
44 Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site Kampala Uganda 10005
45 Yen Hoa Health Clinic CRS Hanoi Vietnam 100000
46 Milton Park CRS Milton Park Harare Zimbabwe

Sponsors and Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Dynavax Technologies Corporation

Investigators

  • Study Chair: Kenneth E. Sherman, MD, PhD, Cincinnati CRS
  • Study Chair: Kristen Marks, MD, Weill Cornell Chelsea CRS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT04193189
Other Study ID Numbers:
  • ACTG A5379
  • 38569
First Posted:
Dec 10, 2019
Last Update Posted:
Jun 22, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis B

Study Results

No Results Posted as of Jun 22, 2022