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HVTN 115

Status
Ongoing
Phase
I
Objective

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 Envs adjuvanted with GLA-SE, administered with or without DNA Mosaic-Tre env, in healthy, HIV-uninfected adults.

Prevention Option(s)
HIV Vaccine
Study Design
Randomized
Arms and Assigned Interventions
Description
Participants will receive 20 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Mode of Delivery
Intramuscular
Products
CH505TF
ARMs
Experimental
Description
Participants will receive 100 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Mode of Delivery
Intramuscular
Products
CH505TF
ARMs
Experimental
Description
Participants will receive 400 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Mode of Delivery
Intramuscular
Products
CH505TF
ARMs
Experimental
Description
Participants will receive placebo at Months 0, 2, 4, 8, and 12.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Description
Participants will receive CH505TF (admixed with GLA-SE) and placebo at Month 0; CH505w53 (admixed with GLA-SE) and placebo at Month 2; CH505w78 (admixed with GLA-SE) and placebo at Month 4; and CH505w100 (admixed with GLA-SE) and placebo at Months 8, 12, and 16.
Mode of Delivery
Intramuscular
Products
CH505TF
ARMs
Experimental
Description
Participants will receive CH505TF (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 0; CH505w53 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 2; CH505w78 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 4; CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Months 8, 12, and 16.
Mode of Delivery
Intramuscular
Products
CH505TF
ARMs
Experimental
Description
Participants will receive CH505TF (admixed with GLA-SE) and placebo at Month 0; CH505TF + CH505w53 (admixed with GLA-SE) and placebo at Month 2; CH505TF + CH505w53 + CH505w78 (admixed with GLA-SE) and placebo at Month 4; CH505w53 + CH505w78 + CH505w100 (admixed with GLA-SE) and placebo at Month 8; CH505w78 + CH505w100 (admixed with GLA-SE) and placebo at Month 12; and CH505w100 (admixed with GLA-SE) and placebo at Month 16.
Mode of Delivery
Intramuscular
Products
CH505TF
ARMs
Experimental
Description
Participants will receive CH505TF (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 0; CH505TF + CH505w53 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 2; CH505TF + CH505w53 + CH505w78 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 4; CH505w53 + CH505w78 + CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 8; CH505w78 + CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 12; and CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 16.
Mode of Delivery
Intramuscular
Products
CH505TF
ARMs
Experimental
Description
Participants will receive two injections of placebo at Months 0, 2, 4, 8, 12, and 16.
Mode of Delivery
Intramuscular
ARMs
Placebo Comparator
Trial Sponsors
DAIDS
October 2017
November 2019
Enrollment
132
18
Years
50
Years
Population
Women
Men
Sites

University of Alabama at Birmingham

Birmingham, Alabama
United States of America

Columbia P&S CRS

New York, NY
United States of America

New York Blood Center

New York, New York
United States of America

Site(s) - Rochester

Rochester, New York
United States of America