HVTN 115/ EnvSeq-1 and CH505

Status:Ongoing
Phase:I
Principal Investigator(s):Magda Sobieszczyk; James Kobie
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. Last updated September 15, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive 20 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive 100 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive 400 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants 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 DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants 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 DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants 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 DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants 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 DeliveryIntramuscular
ARMsExperimental
Official Code: NCT03220724
Related Publications:
Development of a platform-based approach for the clinical production of HIV gp120 envelope glycoprotein vaccine candidates
HVTN Full Group Meeting 2021: Plenary 3
Trial Sponsors: NIAID (DAIDS-ES: 12042)
Start Date
End Date
August 22, 2017
July 19, 2023
Enrollment:107
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women