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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
No
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

Join this Trial

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Study Stats
Protocol No.
20-000042
Category
Infectious Disease
Contact
Lisa Mark
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04193189
For detailed technical eligibility, visit ClinicalTrials.gov.