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Evaluating the Safety and Immunogenicity of HIV-1 Vaccines Based on Chimpanzee Serotypes of Ad Expressing Clade C gp140 and a CH505TF gp120 Protein Boost in Healthy, HIV- Uninfected Adult Participants — HVTN139  

HIV Infections Clinical Trial

Official title:
A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Vaccines Based on Chimpanzee Serotypes of Adenovirus Expressing Clade C gp140 and a CH505TF gp120 Protein Boost in Healthy, HIV- Uninfected Adult Participants

Clinical Trial Summary

The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 vaccines based on chimpanzee serotypes of adenovirus expressing clade C gp140 and a CH505TF gp120 protein boost in healthy, HIV- uninfected adult participants.

Clinical Trial Description

This study will evaluate the safety and tolerability of AdC6-HIVgp140 and AdC7-HIVgp140 at doses of 1 x 10^10 virus particles (vp) and 5 x 10^10 vp, alone and in combination with CH505TF gp120 adjuvanted with GLA-SE in HIV- uninfected adults. Participants will be randomly assigned to 6 groups, separated into low dose (Part A; Groups 1-3) and high dose (Part B; Groups 4-6). Participants in Group 1 (Groups 1-3) will receive 1 x 10^10 vp of AdC6-HIVgp140. Participants in Group 2 will receive 1 x 10^10 vp of AdC7-HIVgp140. Participants in Group 3 will receive Placebo control. Part A participants will undergo 6 months of scheduled clinic visits (main study) followed by AESI (Adverse Events of Special Interest) health contacts at month 12, and then annual health contacts at month 24 and 36. Participants in Group 4 will receive 5 x 10^10 vp of AdC6-HIVgp140 followed by 5 x 10^10 vp of AdC7-HIVgp140 (month 3) and 400 mcg CH505TF with 10 mcg GLA-SE (month 6). Participants in Group 5 will receive 5 x 10^10 vp of AdC7-HIVgp140 followed by 5 x 10^10 vp of AdC6-HIVgp140 (month 3) and 400 mcg CH505TF with 10 mcg GLA-SE (month 6). Participants in Group 6 will receive Placebo control. Part B participants (Group 4-6) will undergo 12 months of scheduled clinic visits (main study) followed by an AESI health contact at month 18, and then annual health contacts at month 24 and 36. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05182125
Study type Interventional
Source HIV Vaccine Trials Network
Contact
Status Active, not recruiting
Phase Phase 1
Start date November 25, 2021
Completion date November 6, 2025
View Details
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