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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 Infants

This 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
Randomized
Blind
Arms and Assigned Interventions
Description
Experimental: 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 Delivery
Intramuscular
Products
CH505TF
GLA-SE
gp120
ARMs
Experimental
Description
Placebo Comparator: Part A, Group 2: Placebo Participants will receive Placebo to be administered as a 0.25 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Experimental: 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 Delivery
Intramuscular
Products
CH505TF
GLA-SE
gp120
ARMs
Experimental
Description
Placebo Comparator: Part B, Group 4: Placebo Participants will receive Placebo to be administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Experimental: 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 Delivery
Intramuscular
Products
CH505TF
GLA-SE
gp120
ARMs
Experimental
Description
Placebo Comparator: Part C, Group 6: Placebo Participants will receive Placebo to be administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Experimental: 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 Delivery
Intramuscular
Products
CH505TF
GLA-SE
gp120
ARMs
Experimental
Description
Placebo Comparator: Part C, Group 8: Placebo Participants will receive Placebo to be administered as a 0.5 mL IM injection, into either thigh at Weeks 0, 8, 16, 32, and 54.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
NIAID, HVTN
November 2020
June 2024
Enrollment
38
0
Months
5
Days
Population
Adolescent/Children
Sites

Perinatal HIV Research Unit

Soweto
South Africa