A Safety and Efficacy Study of ChAdOx1 LS2 (VAC067)
Research type
Research Study
Full title
A Phase I/II Study to assess the safety, immunogenicity and protective efficacy of novel malaria vaccine candidate ChAdOx1 LS2 in healthy UK adults
IRAS ID
226233
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford, CTRG
Eudract number
2017-001049-28
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
Plasmodium falciparum Malaria remains a major global health problem with approximately 200 million cases and 500,000 deaths worldwide annually, mostly in Africa. The majority of these deaths are in children under the age of 5 years old. A malaria vaccine is a key strategy for reducing malaria mortality and achieving the greater goal of global eradication of the disease. Clinical trials of vaccine candidates have only delivered moderate efficacy, someway short of the target outlined for a deployable malaria vaccine by 2030.
ChAdOx1 LS2 is a novel candidate vaccine being developed by Adrian Hill’s group at the University of Oxford and this will be the first clinical trial where it is administered in humans. This vaccine uses a virus that has extra DNA inserted so that after injection, the body makes malaria proteins (but malaria does not develop), so that the immune system builds a response to malaria without having been infected by it. This virus cannot grow and divide in humans after vaccination and has been used safely in several trials by our research group expressing other proteins for vaccination against other diseases.
The study will assess the safety of the vaccinations, and the immune responses to vaccination. 23-31 healthy adult volunteers will be recruited in Oxford, United Kingdom. Immune responses are measured by tests on blood samples. One group of volunteers will receive 2 doses of the vaccine and then be infected with malaria by mosquito bites several weeks after the first vaccination along with a group of control volunteers not receiving vaccines. These are standardised, carefully supervised infection experiments and are used internationally to assess vaccine efficacy: how well the vaccines act to prevent malaria disease. Funding for the study comes from the European Commission.REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0163
Date of REC Opinion
20 Apr 2017
REC opinion
Favourable Opinion