HVTN 086/SAAVI 103

Status:Completed
Phase:I
Principal Investigator(s):Gavin Churchyard, Aurum Institute for Health Research
Objective:The purpose of this study is to evaluayte the safety and immunogenicity of 4 experimental preventitive HIV vaccine regimens in HIV-uninfected adults in South Africa.    last update March 30, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionSAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid at Month 1; Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, with placebo in right deltoid, at Months 3, 6. Placebo comparator: Placebo administered at Months 0, 1, 3, 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionSAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, at Months 0, 3; placebo in right deltoid at Month 1; placebo in each deltoid at Month 6 Placebo comparator: Placebo administered at Months 0, 1, 3, 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionSAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid at Month 1; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with placebo in left deltoid, at Months 3, 6 Placebo comparator: Placebo administered at Months 0, 1, 3, 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionSAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid at Month 1; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid at Months 3, 6; Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, with placebo in right deltoid, at Months 3, 6 Placebo comparator: Placebo administered at Months 0, 1, 3, 6
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01418235
Related Publications:
Sequential Immunization with gp140 Boosts Immune Responses Primed by Modified Vaccinia Ankara or DNA in HIV-Uninfected South African Participants
Trial Sponsors: HVTN, South Africa AIDS Vaccine Initiative
Start Date
End Date
June 1, 2011
June 1, 2015
Enrollment:184
Age range: 18 Years ↔ 45 Years
Population:Cisgender Men, Cisgender Women