Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will evaluate the safety and immune response to the DNA-HIV-PT123 vaccine used in
      combination with one of two protein vaccines (Bivalent Subtype C gp120/MF59 or Bivalent
      Subtype C gp120/AS01B) in healthy, HIV-uninfected adults.
    

Detailed description: 
      The purpose of this study is to evaluate the safety, tolerability, and immune response of the
      DNA-HIV-PT123 vaccine when used in combination with one of two protein vaccines: Bivalent
      Subtype C gp120/MF59 (Protein/MF59) or Bivalent Subtype C gp120/AS01B (Protein/AS01B). These
      protein vaccines may boost the immune response to the DNA vaccine.

      The study will enroll healthy, HIV-uninfected adults. Participants will be randomly assigned
      to one of eight groups, and each group will receive a different sequence of vaccines during
      the study. Groups 1 and 4 will receive the DNA-HIV-PT123 vaccine, the Protein/MF59 vaccine,
      and placebo. Groups 2, 3, 5, 6, and 7 will receive the DNA-HIV-PT123 vaccine, the
      Protein/AS01B vaccine, and placebo. Group 8 will only receive placebo.

      All participants will receive their assigned vaccines at Months 0, 1, 3, and 6. Each of these
      visits will include three injections. Follow-up visits will occur at Week 2 and Months 1.5,
      3.5, 6.25, 6.5, 9, and 12.

      Study visits will include a physical examination, an interview and/or questionnaire, HIV
      testing and HIV risk reduction counseling, and urine and blood collection. Participants may
      optionally choose to provide stool, rectal fluid, cervical fluid, or semen samples.
      Participants will be contacted 6 months after the last scheduled visit by phone, text
      message, or e-mail for information about their health.
    

Intervention name(s): DNA-HIV-PT123 vaccine; Bivalent Subtype C gp120/MF59 vaccine; Bivalent Subtype C gp120/AS01B vaccine; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.; Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.; Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose.; Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
Other intervention name(s): Protein/MF59 vaccine; Protein/AS01B vaccine
Intervention MeSH terms: Vaccines; MF59 oil emulsion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention