Principal Investigator(s):Walter Jaoko; Pontiano Kaleebu; William Kilembe; Eduard Sanders; Paola Cicconi
Objective:A Phase 1 Trial of ChAdOx1- and MVA-vectored Conserved Mosaic HIV-1 Vaccines in Healthy, Adult HIV-1-negative Volunteers in Eastern and Southern Africa.HIV-CORE 006 is a Phase 1 double-blind placebo-controlled trial, in which the mosaic immunogens are delivered by a prime-boost regimen of non-replicating simian adenovirus followed by non-replicating poxvirus MVA. Volunteers will be randomised to receive either the vaccine regimen or placebo at 2 vaccination visits 4 weeks apart. The vaccine regimen consists of a single mosaic prime ChAdOx1.tHIVconsv1 (C1) and a dual boost of MVA.tHIVconsv3 (M3) and MVA.tHIVconsv4 (M4) administered simultaneously. The trial will recruit healthy African adults 18-50 years of age, who are HIV-uninfected and at low risk of HIV infection.Last updated September 16, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Placebo-controlled, Randomized
Arms and Assigned Interventions
DescriptionExperimental: 1: Vaccine At Week 0, volunteers receive 5.0 x 10^10 virus particles (vp) of ChAdOx1.tHIVconsv1 (C1) administered intramuscularly (IM). The dose is divided in 2 and administered in the deltoid muscle of each arm. At week 4,1.0 x 10^8 Plaque forming units (PFU) of MVA.tHIVconsv3 (M3) administered IM and 0.9 x 10^8 PFU of MVA.tHIVconsv4 (M4) are administered IM simultaneously, one into the deltoid muscle of each arm.
Mode of DeliveryIntramuscular
Official Code: NCT04553016
Trial Sponsors: EDCTP, IAVI, KEMRI-Wellcome, University of Nairobi, University of Oxford
Start Date
End Date
August 16, 2021
November 29, 2022
Age range: 18 Years ↔ 50 Years
Population:Cisgender Men, Cisgender Women