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

Prior treatment

• Infection or prior exposure to HBV
• Solid organ transplantation
• Currently receiving chemotherapy
• 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
• 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

Other illness

• Presence of any active or acute AIDS-defining opportunistic infections
• History of ascites, encephalopathy, or variceal hemorrhage
• Diagnosis of chronic kidney disease (CKD) stage G4
• Cancer diagnosis within 5 years
• Known allergy/sensitivity or any hypersensitivity to any HBV vaccine or yeast
• Active, serious infection other than HIV-1

Lab values

• Serum HBsAb level ≥10 mlU/mL or positive at screening or any other time prior to screening

Other

• Chronic use and/or receipt of systemically administered immunosuppressive

• HIV-1 infection
• On current HIV-1 antiretroviral therapy (ART)
• CD4+ T-cell count ≥100 cells/mm\^3
• HIV-1 RNA \<1000 copies/mL
• 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