HVTN 135

Status:Ongoing
Phase:I
Principal Investigator(s):Avy Violari, Georgia Tomaras
Objective:A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the HIV-1 CH505 Transmitted/Founder gp120 Adjuvanted With GLA-SE in Healthy, HIV-exposed Uninfected InfantsThis study will evaluate the safety and immune response in healthy HIV-exposed and uninfected infants to the protein vaccine, CH505TF gp120, adjuvanted with GLA-SE. This study will enroll 38 mother-infant pairs. To quantify the maternal HIV antibody response, mothers will also be enrolled in the study but will not receive study product. Infants will receive the CH505TF gp120 protein adjuvanted with GLA-SE at Weeks 0, 8, 16, 32, and 54. The first dose will be given within the first five days of life.Last updated September 16, 2022
Prevention Option(s):HIV Vaccine
Study Design:Blind, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Part A, Group 1: CH505TF gp120 + GLA-SE Participants will receive 20 mcg Stable CH505TF gp120 admixed with 2.5 mcg GLA-SE, to be administered as a 0.25 mL intramuscular (IM) injection into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part B, Group 3: CH505TF gp120 + GLA-SE Participants will receive 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part C, Group 5: CH505TF gp120 + GLA-SE Participants will receive 20 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part C, Group 7: CH505TF gp120 + GLA-SE Participants will receive 5 mcg Stable CH505TF gp120 admixed with 5 mcg GLA-SE, to be administered as a 0.5 mL IM injection into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT04607408
Trial Sponsors: HVTN, NIAID
Start Date
End Date
November 10, 2020
June 1, 2024
Enrollment:38
Age range: 0 Months ↔ 5 Days
Population:Adolescents and Young People