HIV-CORE 0051
Research type
Research Study
Full title
A phase I/IIa open label trial to assess safety and immunogenicity of candidate T-cell vaccines ChAdOx1.HTI and MVA.HTI given sequentially to healthy HIV-1/2-negative volunteers in Oxford, UK
IRAS ID
261129
Contact name
Paola Cicconi
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Eudract number
2019-000621-47
Duration of Study in the UK
0 years, 12 months, days
Research summary
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 available but 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. One of the main reasons for this is 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 in collaboration with colleagues at Irsicaixa in Barcelona and industry partners have developed novel candidate vaccines against HIV (HTI). 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, 10 individuals aged 18-65 who are in good health and are HIV-negative will be vaccinated at the CCVTM, University of Oxford. Each participant will receive both vaccines 2 months apart, injected into the deltoid muscle of the arm; the purpose of the second vaccine is to increase the effect of the first vaccine. After the second vaccine, volunteers will be followed-up for an additional 6 months, with participants attending 13 visits in total. Blood samples will be collected at each clinic visit for analysis.Summary of Results:
HIV-CORE 0051 Lay Summary Background Human Immunodeficiency Virus (HIV) is a virus that targets the body’s immune system and can lead to AIDS if left untreated. There are 1.8 million new infections each year and there is currently no cure for HIV nor licensed vaccine, which would protect against transmission of HIV infection. In this study, we tested newly developed vaccines called ChAdOx1.HTI and MVA.HTI. Each of these vaccines contain synthetic segments of HIV genes and a vector component, which carries the gene segments into the body’s cells, to elicit an immune response.
How was the trial performed?
The trial was the first time these vaccines had been tested in humans, although similar vaccines have previously been tested in several hundred healthy volunteers, and a small number of volunteers infected with HIV. It took place at a single site in the UK at the Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford. We enrolled 10 healthy, HIV-negative volunteers between 18 and 65 years old. Participants received a dose of ChAdOx1.HTI, followed by a dose of MVA.HTI 28 days later. All volunteers were followed up for 224 days.
What were the objectives of the study?
The main objective of the study was to assess the safety and tolerability of the vaccine by asking participants to report any symptoms or illnesses they experienced. The secondary objective was to analyse the immune responses induced by the vaccine.
What were the results of the study?
All vaccines were shown to be safe and well tolerated. The most commonly reported post-vaccination symptoms were consistent with those typically expected following other viral vector vaccines. These included pain at the injection site, headache, fatigue, myalgia, nausea and general malaise. The majority of symptoms were mild to moderate and resolved within 72 hours of vaccination. No suspected unexpected serious adverse reactions or serious adverse events were seen during the study.
The trial results show the vaccines prompted a good and broad immune response to a number of variants. The results were encouraging for further vaccine research.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
19/EE/0323
Date of REC Opinion
23 Dec 2019
REC opinion
Further Information Favourable Opinion