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UCLA Enrolling People Living with HIV for Hepatitis B Vaccine Study

Response to hepatitis B virus (HBV) vaccination with older, 3-dose series HBV vaccines is suboptimal in persons living with HIV (PLWH). A newer FDA-approved vaccine called HEPLISAV-B may provide a better response in PLWH. UCLA’s CARE Center is seeking HIV-positive volunteers who have previously not responded (not developed hepatitis B surface antibody [HBSAb]) to vaccination with ENGERIX-B or RECOMBIVAX HB.

Objective: To evaluate how a 2-dose or 3-dose HEPLISAV-B vaccine series compares to a standard 3-dose series of ENGERIX-B in generating a seroprotective response.

 

Intervention:

Volunteers will be randomized 1:1:1 to one of the following three arms:

Arm 1: HEPLISAV-B, 0.5 mL dose administered intramuscularly at weeks 0 and 4.

Arm 2: HEPLISAV-B, 0.5 mL dose administered intramuscularly at weeks 0, 4, and 24.

Arm 3: ENGERIX-B, 1 mL dose administered intramuscularly at weeks 0, 4, and 24.

 

Key Inclusion Criteria:

  • Individuals living with HIV at least 18 years old
  • On current ART for more than 56 days
  • CD4 cell count > 100
  • HIV-1 RNA < 1000 copies
  • HBSAb < 10 mlU/mL, nonreactive (negative), or indeterminate
  • Documentation of HBV vaccination > 6 months ago

 

Participants should remain on their non-study provided ART throughout the study

 

Duration of Study: 72 weeks

 

For more information please contact: David Choi, (310) 557-2041, dechoi@mednet.ucla.edu

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