CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 51 enrolled
Drug / intervention
CH505 TF chTrimer +4 morebiological
Likely dose
CH505 TF chTrimer 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04915768
NCT04915768Phase 1Completed
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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.

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Jun 7, 2021·Updated Apr 14, 2026

In Brief

A Phase 1 clinical trial evaluating CH505 TF chTrimer, 3M-05-AF, and 1 other intervention for HIV Infections. Completed, enrolled 51 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJun 7, 2021
Enrollment StartJan 23, 2023
Primary CompletionJul 15, 2025
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 5.1 years ago

Interventions

CH505 TF chTrimerbiological

Combined with adjuvants 3M-052-AF and Alum. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.

3M-05-AFbiological

Combined with CH505 TF chTrimer and Alum adjuvant. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.

Aluminum hydroxide suspensionbiological

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-AFbiological

Combined with CH505 TF chTrimer. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.

CH505 TF chTrimerbiological

Combined with adjuvant 3M-052-AF. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.