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

ACTG A5379

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.

2020-12-14

2024-07-26

2024-07-26

Active (not recruiting)

Early phase I

640

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 640, 'type': 'ACTUAL'}}

2024-05-03