HVTN 300

Status:Ongoing
Phase:I
Principal Investigator(s):Kenneth H Mayer, M.D, Lindsey R Baden, M.D
Objective: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.This is an open-label study to evaluate the safety and immunogenicity of CH505 TF chTrimer and adjuvants 3M-052-AF (imidazoquinoline) + Alum (Aluminum hydroxide suspension) in healthy adults. Adjuvants may make vaccines work better.Last updated September 19, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label
Arms and Assigned Interventions
DescriptionExperimental: Treatment CH505 TF chTrimer plus adjuvants administered at months 0, 2, 4, 8 and 12. 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
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT04915768
Trial Sponsors: NIAID
Start Date
End Date
May 1, 2021
January 3, 2024
Enrollment:12
Age range: 18 Years ↔ 55 Years
Population:Cisgender Men