NCT04553016: HIV-CORE 006

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.

Status unknown Phase 1 Last updated 21 June 2022

What this trial tests

Phase 1 trial testing Vaccine in HIV-1-infection in 88 participants. Status unknown.

Timeline

16 August 2021

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	University of Oxford
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	88
Start date	16 August 2021
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	4 locations across Kenya, Uganda, Zambia

Drugs / interventions tested

• Vaccine
• Placebo

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

University of Oxford

Who can join

Adults 18 to 50, any sex, with HIV-1-infection. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Safety- local and systemic reactogenicity post vaccination
  Time frame: 7 days
  Proportion of volunteers with local and systemic reactogenicity events from Day 0 to Day 7 post vaccination
• Safety - unsolicited Grade 3 or Grade 4 adverse events post vaccination
  Time frame: 28 days
  Proportion of volunteers with Grade 3 or 4 unsolicited adverse events through 28 days post final vaccination
• Safety - vaccine related SAEs
  Time frame: 48 weeks
  Proportion of volunteers with vaccine related serious adverse events (SAEs) collected throughout the study period
• Immunogenicity - HIV-1 specific T-cell responses
  Time frame: 44 weeks
  Proportion of vaccine recipients developing HIV-1-specific T-cell responses

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Advances in Infectious Disease Vaccine Adjuvants.
   Fan J, Jin S, Gilmartin L, Toth I, et al · · 2022 · cited 68× · PMID 35891284 · DOI 10.3390/vaccines10071120
2. Current approaches to HIV vaccine development: a narrative review.
   Kim J, Vasan S, Kim JH, Ake JA. · · 2021 · cited 62× · PMID 34806296 · DOI 10.1002/jia2.25793
3. HIV vaccinology: 2021 update.
   Lee JH, Crotty S. · · 2021 · cited 46× · PMID 34272086 · DOI 10.1016/j.smim.2021.101470
4. Prophylactic HIV-1 vaccine trials: past, present, and future.
   Nkolola JP, Barouch DH. · · 2024 · cited 42× · PMID 38141639 · DOI 10.1016/s2352-3018(23)00264-3
5. Effect of epitope variant co-delivery on the depth of CD8 T cell responses induced by HIV-1 conserved mosaic vaccines.
   Wee EG, Moyo N, Hannoun Z, Giorgi EE, et al · · 2021 · cited 12× · PMID 34169114 · DOI 10.1016/j.omtm.2021.04.018
6. The Question of HIV Vaccine: Why Is a Solution Not Yet Available?
   Libera M, Caputo V, Laterza G, Moudoud L, et al · · 2024 · cited 9× · PMID 38628675 · DOI 10.1155/2024/2147912
7. 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.
   Chanda C, Kibengo F, Mutua M, Ogada F, et al · · 2025 · cited 7× · PMID 40388952 · DOI 10.1016/j.lanmic.2024.101041
8. Generating and measuring effective vaccine-elicited HIV-specific CD8 + T cell responses.
   Borgo GM, Rutishauser RL. · · 2023 · cited 5× · PMID 37751362 · DOI 10.1097/coh.0000000000000824