Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT04177355
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • BG505 SOSIP.664 gp140 — BIOLOGICAL
    Administered by IM injection
  • Placebo — BIOLOGICAL
    Administered by IM injection
  • 3M-052-AF — BIOLOGICAL
    Administered by IM injection
  • CpG 1018 — BIOLOGICAL
    Administered by IM injection
  • GLA-LSQ — BIOLOGICAL
    Administered by IM injection
  • Alum (Aluminum Hydroxide Suspension) — BIOLOGICAL
    Administered by IM injection
  • Trimer 4571 — BIOLOGICAL
    Administered by IM injection

Study Details

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.

Key Dates

First listed
Nov 26, 2019
Start date
Jan 13, 2020
Status verified
May 2025
Primary completion
Nov 4, 2024
Completion
Nov 4, 2024

Study Design

Enrollment
127 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
    Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 1 mcg of 3M-052-AF and 500 mcg of Aluminum Hydroxide Suspension (Alum), as one intramuscular (IM) injection at Months 0 and 2, with optional second boost at Month 6.
  • Placebo Comparator: Part A, Group 1 (P1): Placebo
    Participants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6.
  • Experimental: Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
    Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 5 mcg of 3M-052-AF and 500 mcg of Alum, as one IM injection at Months 0 and 2, with optional second boost at Month 6.
  • Placebo Comparator: Part A, Group 2 (P2): Placebo
    Participants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6.
  • Experimental: Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum
    Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 300 mcg of CpG 1018 and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6.
  • Placebo Comparator: Part B, Group 3 (P3): Placebo
    Participants will receive placebo as one IM injection at Months 0, 2, and 6.
  • Experimental: Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum
    Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with either 1 mcg or 5 mcg of 3M-052-AF (the highest tolerated dose from Part A), and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6.
  • Placebo Comparator: Group 4 (P4): Placebo
    Participants will receive placebo as one IM injection at Months 0, 2, and 6.
  • Experimental: Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ
    Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with GLA-LSQ (GLA 5 mcg, and QS-21 2 mcg), as one IM injection at Months 0, 2, and 6.
  • Placebo Comparator: Part B, Group 5 (P5): Placebo
    Participants will receive placebo as one IM injection at Months 0, 2, and 6.
  • Experimental: Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum
    Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 500 mcg of Alum, administered as one IM injection at Months 0, 2, and 6.
  • Placebo Comparator: Part B, Group 6 (P6): Placebo
    Participants will receive placebo as one IM injection at Months 0, 2, and 6.
  • Experimental: Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum
    Participants will receive BG505 SOSIP.664 gp140, 100 mcg admixed with 3M-052-AF, 3 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose intramuscularly (IM) at months 0, 2, and 6.
  • Placebo Comparator: Part C, Group 7 (P7): Placebo
    Participants will receive placebo as one IM injection at Months 0, 2, and 6.
  • Experimental: Part C, Group 8 (T8): Trimer 4571 + Alum
    Participants will receive Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose IM at months 0, 2, and 6.
  • Placebo Comparator: Part C, Group 8 (P8): Placebo
    Participants will receive placebo as one IM injection at Months 0, 2, and 6.

Primary Outcome Measure

Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness [ Time Frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6 ]

Locations (10)

FacilityCityStateZIPSite coordinators
Alabama CRSBirminghamAlabama35294-
The Ponce de Leon Center CRSAtlantaGeorgia30308-2012-
The Hope Clinic of the Emory Vaccine Center CRSDecaturGeorgia30030-
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)BostonMassachusetts02115-6110-
Columbia P&S CRSNew YorkNew York10032-
New York Blood Center CRS (Site 31801)New YorkNew York10065-
University of Rochester Vaccines to Prevent HIV Infection CRSRochesterNew York14642-
Penn Prevention CRSPhiladelphiaPennsylvania19104-
University of Pittsburgh CRSPittsburghPennsylvania15213-
Seattle Vaccine and Prevention CRSSeattleWashington98109-1024-

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Alabama CRS· Birmingham, ALThe Ponce de Leon Center CRS· Atlanta, GAThe Hope Clinic of the Emory Vaccine Center CRS· Decatur, GABrigham and Women's Hospital Vaccine CRS (BWH VCRS)· Boston, MAColumbia P&S CRS· New York, NYNew York Blood Center CRS· New York, NY

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