NCT04915768

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

A First-in-human Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of Stabilized CH505 TF chTrimer in Healthy, HIV-uninfected Adult Participants.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

The primary hypothesis is that the CH505 TF chTrimer vaccine will expand B cell precursor lineages capable of ultimately producing autologous and heterologous Tier 2 broadly neutralizing antibodies (bnAbs). Participants receive CH505 TF chTrimer plus 3M-052-AF (at either a 3 mcg dose or a 5 mcg dose), with or without Alum, via two intramuscular injections administered five times throughout the study. Participants are evaluated for safety and immune responses through blood collection at specified timepoints throughout the study. Each participant has up to 18 months of scheduled clinic visits and a follow-up safety assessment 12 months after their final vaccination.

Conditions

• HIV Infections

Interventions

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

Timeline

• Start date: 2023-01-23
• Primary completion: 2025-07-15
• Completion: 2025-07-15
• First posted: 2021-06-07
• Last updated: 2026-04-14
• Results posted: 2026-02-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study