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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193189
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
Dynavax Technologies Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

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
HIV Infection Hepatitis B 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : August 7, 2020
Estimated Primary Completion Date : December 5, 2021
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 ]
  2. Occurrence of Adverse events (AEs) [ Time Frame: 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 [ Time Frame: Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72 ]
  2. HBsAb titer [ Time Frame: Weeks 4, 8, 12, 24, 28, 32, 48, 52 and 72 ]
  3. Occurrence of Grade ≥2 AEs within 4 weeks after each injection [ Time Frame: From vaccination initiation to Week 28 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193189


Locations
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United States, California
UCSD Antiviral Research Center CRS
San Diego, California, United States, 92103
Contact: Steven Hendrickx, R.N.    619-543-6968    smhendrickx@ucsd.edu   
Ucsf Hiv/Aids Crs
San Francisco, California, United States, 94110
Contact: John Dwyer    415-476-4082 ext 353    Jay.Dwyer@ucsf.edu   
United States, Colorado
University of Colorado Hospital CRS
Aurora, Colorado, United States, 80045
Contact: Suzanne Fiorillo, M.S.P.H.    303-724-5931    suzanne.fiorillo@ucdenver.edu   
United States, Illinois
Rush University CRS
Chicago, Illinois, United States, 60612
Contact: Mark Mall, R.N.    312-942-5865    mark_mall@rush.edu   
United States, Massachusetts
Massachusetts General Hospital CRS (MGH CRS)
Boston, Massachusetts, United States, 02114
Contact: Theresa Flynn, R.N., M.S.N., A.N.P., B.S.N.    617-724-0072    tflynn@partners.org   
United States, Missouri
Washington University Therapeutics (WT) CRS
Saint Louis, Missouri, United States, 63110-1010
Contact: Michael K. Klebert    314-747-1098    mklebert@wustl.edu   
United States, New Jersey
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States, 07103
Contact: Rondalya DeShields, R.N., B.S.N.    973-972-3729    deshierd@njms.rutgers.edu   
United States, North Carolina
Chapel Hill CRS
Chapel Hill, North Carolina, United States, 27599
Contact: Becky Straub, B.S.N., M.P.H., R.N.    919-843-9975    bstraub@med.unc.edu   
United States, Ohio
Cincinnati Clinical Research Site
Cincinnati, Ohio, United States, 45219
Contact: Sharon Kohrs, R.N., B.S.N.    513-584-6383    kohrssd@ucmail.uc.edu   
Case Clinical Research Site
Cleveland, Ohio, United States, 44106
Contact: Jane Baum, R.N.    216-844-2546    jb@clevelandactu.org   
Ohio State University CRS
Columbus, Ohio, United States, 43210
Contact: Kathy Watson, B.S.N., R.N.    614-293-5856    kathy.watson@osumc.edu   
United States, Pennsylvania
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dawn R. Weinman    412-383-1748    drw38@pitt.edu   
United States, Texas
Trinity Health and Wellness Center CRS
Dallas, Texas, United States, 75208
Contact: Lauren Rogers, CCRC    972-807-7370    lauren.rogers@aidsarms.org   
Brazil
Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS
Rio De Janeiro, Brazil, 21040-360
Contact: Sandra W. Cardoso, Ph.D., M.D.    55-21-22707064    sandra.wagner@ipec.fiocruz.br   
India
Chennai Antiviral Research and Treatment (CART) CRS
Chennai, Tamil Nadu, India, 600113
Contact: Faith E. Samson    91-44-39106811    beulah@cartcrs.org   
Thailand
Thai Red Cross AIDS Research Centre (TRC-ARC) CRS
Pathumwan, Bangkok, Thailand, 10330
Contact: Parawee Thongpaeng    662-6523040 ext 106    parawee.t@hivnat.org   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Dynavax Technologies Corporation
Investigators
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Study Chair: Kenneth E. Sherman, MD, PhD Cincinnati CRS
Study Chair: Kristen Marks, MD Weill Cornell Chelsea CRS
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04193189    
Other Study ID Numbers: ACTG A5379
38569 ( Registry Identifier: DAIDS-ES Registry Number )
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie results in the publication, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months following publication and available throughout period of funding of the AIDS Clinical Trials Group by NIH.
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://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an AIDS Clinical Trials Group Data Use Agreement before receiving the data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Virus Diseases
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Viral, Human