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

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).

Timeline

Start

2023-01-23

Primary completion

2025-07-15

Completion

2025-07-15

Publications

• Walsh SR, Hahn WO, Williams WB, Hyrien O, Yu PC, Parks KR, Edwards RJ, Parks R, Barr M, Polakowski LL, Tindale I, Jones M, Yurdadon C, Burnham R, Yeh CH, Heptinstall J, Seaton KE, Andriesen JG, Sagawa Z, Miner MD, De Rosa S, McElrath MJ, Corey L, Tomaras GD, Montefiori DC, Haynes BF, Mayer KH, Baden LR; NIAID HVTN 300 Study Group. Safety and immunogenicity of an HIV envelope trimer immunogen that elicits CD4 binding site neutralizing antibody precursors (HVTN 300). medRxiv [Preprint]. 2026 Apr 3:2026.03.31.26349761. doi: 10.64898/2026.03.31.26349761.

Drugs

Indications