A Study to Test Three Experimental HIV Vaccines in Healthy Adults.

Summary

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. The trial is designed to enrol 88 healthy men and women, who will be randomised to receive either the vaccine regimen or placebo in a ratio of 72:16: * Vaccine Arm (ChAdOx1.tHIVconsv1 prime followed by MVA.tHIVconsv3 and MVA.tHIVconsv4 boost at 4 weeks after enrolment); 72 vaccine recipients; * Placebo Arm; 16 recipients To maintain blinding, all volunteers will receive two injections with half dose into the deltoid region of each arm of ChAdOx1.tHIVconsv1 or placebo at enrolment, and two injections (MVA.tHIVconsv3 or placebo into one deltoid region and MVA.tHIVconsv4 or placebo into the other) at 4 weeks after enrolment. The primary goal of assessing safety and immunogenicity will be served by weighting the randomisation toward vaccinees.

Timeline

Start

2021-08-16

Primary completion

2022-11

Completion

2022-11

Publications

• Chanda C, Kibengo F, Mutua M, Ogada F, Muturi-Kioi V, Akis Yildirim BM, Amondi M, Baines A, Basajja V, Borthwick N, Bosire K, Chambula E, Chetty P, Chinyenze K, Chirro O, Crook A, De Bont J, Fernandez N, Ejou P, Farah B, Glaze M, Gombe B, Gumbe A, Hayes P, Itwi S, Juma S, Kabarambi A, Kabengele C, Kafeero P, Kakande A, Kanungi J, Kidega W, King D, Mahira R, Malogo R, Matsoso M, Michelo C, Moyo A, Mugaba S, Mugenya I, Muhumuza P, Mujadidi YF, Muriuki M, Musale V, Mutua G, Muwowo M, Mwale F, Mwangi I, Nakimbugwe M, Namuyanja A, Nduati E, Nielsen L, Nyange J, Oino G, Okech B, Omosa-Manyonyi G, Otieno D, Palmer S, Phiri H, Ramko K, Rutishauser RL, Sayeed E, Sajabi R, Serwanga J, G-T Wee E, Wenden C, Cicconi P, Fast P, Gilmour J, Jaoko W, Kaleebu P, Kilembe W, Kuipers H, Sanders EJ, Hanke T. Safety and broad immunogenicity of HIVconsvX conserved mosaic candidate T-cell vaccines vectored by ChAdOx1 and MVA in HIV-CORE 006: a double-blind, randomised, placebo-controlled phase 1 trial in healthy adults living without HIV-1 in eastern and southern Africa. Lancet Microbe. 2025 Jun;6(6):101041. doi: 10.1016/j.lanmic.2024.101041. Epub 2025 May 16.

Drugs

Indications