B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
a study on HIV/AIDS Hepatitis B
Summary
- Eligibility
- for people ages 18-70 (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study startedestimated completion
Description
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.
Details
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.
Keywords
HIV Infection Hepatitis B HEPLISAV-B ENGERIX-B
Eligibility
You can join if…
Open to people ages 18-70
, Groups A and B
- HIV-1 infection
- On current HIV-1 antiretroviral therapy (ART)
CD4+ T-cell count ≥100 cells/mm3
- 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
You CAN'T join if...
, 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
Locations
- UCSD Antiviral Research Center CRS
San Diego California 92103 United States - Ucsf Hiv/Aids Crs
San Francisco California 94110 United States
Details
- Status
- not yet accepting patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- ID
- NCT04193189
- Phase
- Phase 3
- Study Type
- Interventional
- Last Updated