Safety and immunogenicity of MAP vaccine ChAdOx2 HAV (HAV001)
Research type
Research Study
Full title
A phase I study to determine the safety and immunogenicity of the candidate MAP vaccine ChAdOx2 HAV
IRAS ID
214768
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford, CTRG
Eudract number
2016-004226-42
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
The purpose of this study is to assess the new Mycobacterium avium subspecies paratuberculosis (MAP) vaccine, ChAdOx2 HAV at different doses. MAP is a bacteria found in the environment which is known to cause a chronic bowel disease in cattle. The scientific evidence suggests it can also play an important role in the development of Crohn’s disease in humans. A vaccine against MAP could potentially lead to clinical improvement of Crohn’s disease.
This study will enable us to assess the safety of the vaccine and the extent of the immune response in healthy volunteers at different doses. We will do this by giving participants one dose of the vaccine and then will take blood samples for safety test and to collect information about the immune system. We will also record any symptoms that occur after vaccination. If the low dose of the vaccine is safe, we will vaccinate further volunteers with a higher dose. If the vaccine causes too many side effects at a certain dose, we will not raise the dose of the vaccine any higher. This is the first time this vaccine has been administered to humans. Up to 18 volunteers will be vaccinated in total.
Healthy volunteers will be recruited in England at the Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, Oxford.REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0545
Date of REC Opinion
21 Nov 2016
REC opinion
Favourable Opinion