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

Prevention

Study Type

Interventional

Phase

Phase III/IV

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

70 Years

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