Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Details

This phase III/IV study will evaluate the 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 (Group A) and individuals who are naïve to HBV vaccination (Group B).

Group A (HBV vaccine non-responders)

The study is designed as an open-label three-arm study to evaluate whether:

  1. HEPLISAV-B vaccination given as a two-dose series achieves non-inferior seroprotection response (SPR) compared to standard dose ENGERIX-B.
  2. HEPLISAV-B vaccination given as a three-dose series achieves superior SPR proportion compared to standard dose ENGERIX-B.

Participants are randomized in 1:1:1 ratio to the following study arms, stratified by sex at birth (male vs. female) and diabetes diagnosis status (yes vs. no):

  • Arm 1: Two doses of HEPLISAV-B at weeks 0 and 4.
  • Arm 2: Three doses of HEPLISAV-B at weeks 0, 4, and 24.
  • Arm 3: Three doses of ENGERIX-B at weeks 0, 4, and 24.

The target sample size in Group A is 561 participants, 187 participants in each arm.

Group B (Naïve to HBV vaccination)

Group B study is a single arm evaluation of vaccine response and safety of three doses of HEPLISAV-B. The target sample size is 73 participants.

All participants will remain on their non-study-provided antiretroviral therapy (ART) throughout the study. Participants in both groups will attend several study visits through Week 72. Visits may include physical examinations and blood collection. For 7 days after each vaccination, participants will record temperature and any reactions they have to the vaccine.

Keywords

HIV Infection Hepatitis B HEPLISAV-B ENGERIX-B

Eligibility

You can join if…

Open to people ages 18-70

, Groups A and B

  • HIV-1 infection
  • On current HIV-1 antiretroviral therapy (ART)
  • CD4+ T-cell count ≥100 cells/mm3

  • 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

You CAN'T join if...

, 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 prior to study entry

Exclusion Criteria, Group B only

  • Known HBV vaccination prior to study entry

Locations

  • Ucsf Hiv/Aids Crs
    San Francisco California 94110 United States
  • UCSD Antiviral Research Center CRS
    San Diego California 92103 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
ID
NCT04193189
Phase
Phase 3
Study Type
Interventional
Last Updated