Evaluating the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.

Part of paid clinical trials in Decatur, Georgia.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT04915768
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • CH505 TF chTrimer — BIOLOGICAL
    Combined with adjuvants 3M-052-AF and Alum. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.
  • 3M-05-AF — BIOLOGICAL
    Combined with CH505 TF chTrimer and Alum adjuvant. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.
  • Aluminum hydroxide suspension — BIOLOGICAL
    Combined with CH505 TF chTrimer and 3M-052-AF adjuvant. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle
  • 3M-05-AF — BIOLOGICAL
    Combined with CH505 TF chTrimer. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.
  • CH505 TF chTrimer — BIOLOGICAL
    Combined with adjuvant 3M-052-AF. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.

Study Details

This is an open-label Phase 1 study to examine the safety and immunogenicity of the CH505 TF chTrimer vaccine with 3M-052-AF +/- Alum adjuvant in healthy adults. The primary hypothesis is that the CH505 TF chTrimer will expand CH103-like B-cell precursors. HVTN 300 Part A examined the safety and immunogenicity of the CH505TF chTrimer with 5 mcg 3M-052-AF + 500 mcg Alum. HVTN 300 Part B was added to this protocol with a goal of assessing the optimal dosing and combination of 3M-052-AF and Alum adjuvant, that can potentially lead to improved neutralizing antibody activity and decreased reactogenicity, compared to Part A. Three groups were added to Part B (Group 2: 3 mcg 3M-052-AF without Alum, Group 3: 3 mcg 3M-052 with Alum, and Group 4: 5 mcg 3M-052-AF without Alum). HVTN 300 Part B is being added to this protocol with a goal of assessing the optimal dosing and combination of 3M-052-AF and Alum adjuvant, that can potentially lead to improved neutralizing antibody activity and decreased reactogenicity, compared to Part A. Three groups have been added to Part B (Group 2: 3 mcg 3M-052-AF without Alum, Group 3: 3 mcg 3M-052 with Alum, and Group 4: 5 mcg 3M-052-AF without Alum).

Key Dates

First listed
Jun 7, 2021
Start date
Jan 23, 2023
Status verified
Mar 2026
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Group 1: Treatment
    CH505 TF chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide suspension, administered at months 0, 2, 4, 8 and 12.
  • Experimental: Group 2: Treatment
    CH505 TF chTrimer 300 mcg admixed with (3 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.
  • Experimental: Group 3: Treatment
    CH505 cTrimer, 300 mcg admixed with (3 mcg) 3M-052-AF + (500 mcg) Aluminum Hydroxide suspension (Alum) administered at months 0, 2, 4, 8 and 12.\* \*On October 13, 2023, errors were identified in the study injection preparation for this Group. The instructions below state that the doses for injections in Group 3 should be 300 mcg of the study vaccine + 3 mcg of 3M-052-AF adjuvant + 500 mcg of Alum adjuvant. However, the step-by-step instructions below for preparing the injection result in 2.2 mcg of 3M-052-AF (instead of 3 mcg) and 556 mcg of Alum (instead of 500 mcg). Thus, Group 3 participants got less 3M-052-AF than intended and more Alum than intended.
  • Experimental: Group 4: Treatment
    CH505 chTrimer 300 mcg admixed with (5 mcg) 3M-052-AF administered at months 0, 2, 4, 8 and 12.

Primary Outcome Measure

Number of Participants Reporting Local Reactogenicity Events Signs and Symptoms: Erythema and/or Induration [ Time Frame: Measured through 7 days after each study product administration at Study Day 0 (Month 0), Day 56 (Month 2), Day 112 (Month 4), Day 224 (Month 8), and Day 364 (Month 12) ]

Locations (3)

FacilityCityStateZIPSite coordinators
The Hope Clinic of the Emory Vaccine Center CRSDecaturGeorgia30030-
Brigham and Women's CRSBostonMassachusetts02115-
Vanderbilt Vaccine (VV) CRSNashvilleTennessee30030-

Find similar trials in Decatur, GA

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By research site
The Hope Clinic of the Emory Vaccine Center CRS· Decatur, GABrigham and Women's CRS· Boston, MAVanderbilt Vaccine (VV) CRS· Nashville, TN

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