HVTN 124/ PDPHV-201401
Status:Completed
Phase:I
Principal Investigator(s):Ian Frank, Turner Overton
Objective:Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected AdultsThe purpose of this study is to evaluate the safety, tolerability, and immunogenicity of env (A,B,C,A/E)/gag (C) DNA and gp120 (A,B,C,A/E) protein/GLA-SE HIV-1 vaccines (PDPHV-201401) as a prime-boost regimen or co-administered in repeated doses, in healthy, HIV-1-uninfected adults.Result summary: (Presented by Shan Lu at HVTN 2021) Safe and well tolerated; peak immunization observed two months after the last dose. The preliminary data from the peak immunogenicity analyses are very encouraging and support the advancement of this vaccine candidate to further clinical testing in WHV 138Last updated September 16, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant at Day 0 and Month 2.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive 2 mg of env (A,B,C,A/E)/gag (C) DNA vaccine and placebo at Day 0 and Months 1 and 3. Participants will receive 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant and a placebo vaccine at Months 6 and 8.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive 2 mg of the env (A,B,C,A/E)/gag (C) DNA vaccine and 400 mcg of gp120 (A,B,C,A/E) protein vaccine admixed with GLA-SE adjuvant at Day 0 and Months 1, 3, 6, and 8.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT03409276
Trial Sponsors:
NIAID (DAIDS-ES: 38302)
Start Date
End Date
March 16, 2018
October 22, 2020
Enrollment:60
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women