HIV-CORE 0052
Research type
Research Study
Full title
A phase I dose escalation open label trial to assess safety and immunogenicity of candidate ChadOx1- and MVA- vectored Conserved Mosaic HIV-1 vaccines, given sequentially to healthy HIV-1/2 negative adult volunteers in Oxford UK.
IRAS ID
273882
Contact name
Paola Cicconi
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Eudract number
2019-003973-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 31 days
Research summary
Worldwide, an estimated 36.7 million people are chronically infected with Human Immunodeficiency Virus (HIV), the virus that, if untreated, causes AIDS. Highly effective drug treatments are not always available in resource poor settings, their efficacy requires rigorous dosing regimens and there are dangerous side-effects. Vaccination is the most effective way to prevent many infectious diseases, but developing effective vaccines against HIV is extremely challenging, largely due to the extraordinary ability of the virus to change its genes. There is a great need for a safe, effective HIV vaccine. Researchers at the University of Oxford have developed novel candidate conserved mosaic vaccines against HIV (tHIVconsvX). These have been inserted into chimpanzee adenovirus (ChAd) and modified vaccinia virus Ankara (MVA) backbones, both of which have excellent safety records. The aims of this Horizon 2020 funded study are to see if these vaccine candidates are safe, well tolerated and induce an immune response against HIV infection. During this study, 13 individuals aged 18-65 who are in good health and are HIV-negative will be vaccinated at the CCVTM, University of Oxford. The first three participants will receive a low dose of ChAdOx1.tHIvconsv1. They will be followed up for four months, attending 7 visits in total. The remaining 10 participants will receive a higher dose of ChAdOx1.tHIVconsv1, followed one month later by one dose each of MVA.tHIVconsv3 and MVA.tHIVconsv4 (delivered separately, but at the same visit). All vaccines will be injected into the deltoid muscle of the arm; the purpose of the second vaccination is to increase the effect of the first vaccine. After the second vaccination, volunteers will be followed-up for an additional 4 months, with participants attending 12 visits over 5 months in total. Blood samples will be collected at each clinic visit for safety and analysis.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0036
Date of REC Opinion
20 Mar 2020
REC opinion
Further Information Favourable Opinion