Evaluating the Safety and Immunogenicity of EnvSeq-1 and CH505 M5 gp120 Envs Adjuvanted With GLA-SE in Healthy, HIV-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
      EnvSeq-1 and CH505 M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 and CH505
      M5 gp120 Envs adjuvanted with GLA-SE in healthy, HIV-uninfected adults. The three individual
      EnvSeq-1 HIV vaccine Envs used in this study are called CH505TF gp120, CH505w53 gp120, and
      CH505w78 gp120.

      This study will take place in two parts: Part A and Part B. Participants in Part A will be
      randomly assigned to one of four groups. Participants in each group will receive CH505TF
      (admixed with GLA-SE) or placebo by intramuscular (IM) injection at Months 0, 2, 4, 8, and
      12.

      Study researchers will evaluate participant data from Part A of the study prior to enrolling
      participants into Part B of the study. Researchers will also evaluate data from Part A to
      determine the dosing for Part B.

      Participants in Part B will be randomly assigned to one of four groups. Participants in each
      group will receive IM injections at Months 0, 2, 4, 8, 12, and 16. GLA-SE will be admixed
      with all the CH505 gp120 vaccines. Part B, Group 5 will follow a sequential approach to
      EnvSeq-1 vaccine administration with administration of the CH505TF vaccine at Month 0, then
      CH505w53 at Month 2, and CH505w78 at Months 4, 8, 12, and 16. Part B, Group 6 participants
      will follow an additive approach to EnvSeq-1 administration with administration of the
      CH505TF vaccine at Month 0; then the CH505TF and CH505w53 vaccines at Month 2; then the
      CH505TF, CH505w53 and CH505w78 vaccines at Month 4; then the CH505w53 and CH505w78 vaccines
      at Month 8; then the CH505w78 vaccine at Months 12 and 16. Part B, Group 7 participants will
      receive CH505 M5 at Months 0, 2, 4, 8, 12 and 16. Part B, Group 8 participants will receive
      placebo injections at each time point.

      Additional study visits will occur through Month 18 for participants in Part A and through
      Month 22 for participants in Part B. Visits may include physical examinations and clinical
      assessments; blood, urine, and stool collection; HIV testing; risk reduction counseling; and
      interviews/questionnaires. Study staff will contact participants for follow-up health
      monitoring at Month 24 for participants in Part A and at Month 28 for participants in Part B.

      Part C will be an open-label study arm using the EnvSeq-1 proteins in sequential
      administration (CH505TF, CH505w53, and CH505w78 gp120s) at the same dose as in Part B (400
      mcg) to allow for in-depth analysis of B cell precursor frequency.
    

Intervention name(s): CH505TF; CH505w53; CH505w78; CH505 M5; GLA-SE adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Administered by intramuscular (IM) injection in the thigh; Administered by IM injection in the thigh; Administered by IM injection in the thigh; Administered by IM injection in the thigh; Admixed with all CH505 gp120 proteins; Administered by IM injection in the thigh
Other intervention name(s): CH505TF gp120; CH505w53 gp120; CH505w78 gp120; CH505 M5 gp120
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention