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 Francisco, 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, HEPLISAV-B (three injections)
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
- Ucsf Hiv/Aids Crs
accepting new patients
San Francisco California 94110 United States - UCLA CARE Center CRS
accepting new patients
Los Angeles California 90035-4709 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- ID
- NCT04193189
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 634 study participants
- Last Updated
Frequently Asked Questions
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT04193189.