Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env
      (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as
      a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected
      adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag
      (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost
      regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.

      The study will be conducted in two parts (Part A and Part B).

      Participants in Part A will be randomly assigned to either Group 1 (Treatment) or Group 1
      (Control). Participants in Group 1 (Treatment) will receive the gp120 (A,B,C,A/E) protein
      vaccine admixed with GLA-SE adjuvant on Day 0 and Month 2. Participants in Group 1 (Control)
      will receive placebo on Day 0 and Month 2.

      Researchers will evaluate study data from Part A before enrolling participants in Part B.

      Participants in Part B will be enrolled in either Groups 2 or 3. Within Group 2, participants
      will be randomly assigned to either Group 2 (Treatment) or Group 2 (Control). Participants in
      Group 2 (Treatment) will receive the env (A,B,C,A/E)/gag (C) DNA vaccine and placebo on Day 0
      and Months 1 and 3. At Months 6 and 8, participants will receive the gp120 (A,B,C,A/E)
      protein vaccine admixed with GLA-SE adjuvant and a placebo vaccine. Participants in Group 2
      (Control) will receive placebo on Day 0 and Months 1, 3, 6, and 8.

      Participants in Group 3 will be randomly assigned to either Group 3 (Treatment) or Group 3
      (Control). Participants in Group 3 (Treatment) will receive the env (A,B,C,A/E)/gag (C) DNA
      vaccine and the gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant on Day 0 and
      Months 1, 3, 6, and 8. Participants in Group 3 (Control) will receive placebo on Day 0 and
      Months 1, 3, 6, and 8.

      Study visits for participants in Part A will occur on Day 0, Week 2, and Months 2, 2.5, 5,
      and 8. Study visits for participants in Part B will occur on Day 0, Week 2, and Months 1,
      1.5, 3, 3.5, 6, 6.5, 8, 8 + 1 Week, 8.5, 11, and 14. Visits may include physical
      examinations, blood and urine collection, HIV testing, risk reduction counseling, and
      questionnaires. Participants in Part B may also have optional saliva, semen, cervical fluid,
      rectal fluid, and stool sample collection.

      Study staff will contact all participants 12 months after the last vaccination for follow-up
      health monitoring.
    

Intervention name(s): env (A,B,C,A/E)/gag (C) DNA Vaccine; gp120 (A,B,C,A/E) Protein Vaccine; Placebo; GLA-SE adjuvant
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Administered by intramuscular injection in the deltoid.; Administered by intramuscular injection in the deltoid.; Sodium Chloride for Injection, USP 0.9%; Administered by intramuscular injection in the deltoid.; Administered by intramuscular injection in the deltoid.
Other intervention name(s): Polyvalent DNA (PDPHV-201401) Plasmid; PDPHV-201401 Recombinant Proteins gp120A, gp120B, gp120C, gp120AE; glucopyranosyl lipid adjuvant-stable emulsion
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention