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Actively Recruiting
B-Enhancement of HBV Vaccination in Persons Living With HIV (BEe-HIVe): Evaluation of HEPLISAV-B
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
20-000042
Category
Infectious Disease
Principal Investigator
Location
- UCLA Santa Monica
- UCLA Westwood