HVTN 139

Status:Ongoing
Phase:I
Principal Investigator(s):Ameena Goga
Objective: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 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. Last updated September 18, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Part A, Group 1: AdC6-HIVgp140 Participants will receive 1 x 10^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part A, Group 2: AdC7-HIVgp140 Participants will receive 1 x 10^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part B, Group 4: AdC6-HIVgp140 + AdC7-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE Participants will receive 5 x 10^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. Then 5 x 10^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 3. Then 400 mcg CH505TF gp120 admixed with 10 mcg GLA-SE administered as a 1mL IM injection into either thigh unless medically contraindicated at month 6.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part B, Group 5: AdC7-HIVgp140 + AdC6-HIVgp140 + 400 mcg CH505TF gp120/GLA-SE Participants will receive 5 x 10^10 vp AdC7-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 0. Then 5 x 10^10 vp AdC6-HIVgp140 to be administered as two separate 1 mL IM injections into the deltoid of the non-dominant arm unless medically contraindicated at month 3. Then 400 mcg CH505TF gp120 admixed with 10 mcg GLA-SE administered as a 1mL IM injection into either thigh unless medically contraindicated at month 6.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT05182125
Trial Sponsors: HVTN, NIAID
Start Date
End Date
November 25, 2021
November 6, 2025
Enrollment:34
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women