Status and phase
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About
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.
Full 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:
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):
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria, Groups A and B
Inclusion Criteria, Group A only
Inclusion Criterion, Group B only
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:
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
Exclusion Criterion, Group B only
Primary purpose
Allocation
Interventional model
Masking
640 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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