A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines

Summary

The object of the study is to assess the safety profile of candidate vaccines ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVcnsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers. In addition, the study will assess the immune responses generated of the candidate vaccines ChAdOx1.tHIVconsv1, MV.tHIVconsv3 and MVA.tHIVconsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers. 3 healthy, HIV-1 negative adult volunteers will receive one vaccination of low dose ChAdOx1.tHIVconsv1. A further 10 healthy, HIV-1 negative adult volunteers will receive a higher dose of ChAdOx1.tHIVconsv1, followed by one vaccination each of MVA.tHIVconsv3 and MVA.tHIVconsv4 4 weeks later.

Timeline

Start

2021-07-03

Primary completion

2022-08-03

Completion

2022-08-03

Publications

• Borthwick N, Fernandez N, Hayes PJ, Wee EG, Akis Yildirim BM, Baines A, Baker M, Byard N, Conway O, Glaze M, Jenkin D, Larkworthy C, Luciw M, Platt A, Poulton I, Thomas M, Quaddy J, Watson M, Crook A, Cicconi P, Hanke T. Safety and immunogenicity of the ChAdOx1-MVA-vectored conserved mosaic HIVconsvX candidate T-cell vaccines in HIV-CORE 005.2, an open-label, dose-escalation, first-in-human, phase 1 trial in adults living without HIV-1 in the UK. Lancet Microbe. 2025 Mar;6(3):100956. doi: 10.1016/j.lanmic.2024.100956. Epub 2024 Nov 26.

Drugs

Indications