Safety and Immunogenicity of a candidate CHIKV vaccine (CHIK001)
Research type
Research Study
Full title
A phase I study to determine the safety and immunogenicity of the candidate Chikungunya Virus (CHIKV) vaccine ChAdOx1 Chik in healthy adult volunteers
IRAS ID
235713
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford, CTRG
Eudract number
2017-004483-35
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
The purpose of this study is to test a new vaccine against the Chikungunya Virus (CHIKV) in healthy volunteers. \nChikungunya fever is a disease caused by CHIKV and it is transmitted to humans through a mosquito bite. It has been identified in over 100 countries, causing approximately 1 million cases worldwide. The disease typically consists of an acute illness characterised by fever, skin rash, muscle aches and severe joint pains (which are often incapacitating), lasting weeks to months.\nThere are currently no available treatments or licensed vaccines and strategies tackling the control of the mosquito are extremely difficult to implement. Fatal cases are rare, but they have been observed in new-born and elderly individuals, as well as in those with medical conditions such as diabetes or cardiovascular, respiratory, and neurologic disorders \nThe study will enable us to assess the safety of the new vaccine called ChAdOx1 Chik and the extent of the immune response in healthy volunteers. We will do this by giving participants one dose of the vaccine in addition to doing blood tests and collecting information about any symptoms that occur after vaccination. In this study, healthy adult volunteers will receive a single dose of a new candidate vaccine at different doses. The objective of this first-in-human study is to find the optimal dose of the vaccine, balancing immune responses and profile of adverse events.\nHealthy volunteers aged 18-50 will be recruited in Oxford and vaccinated at the Centre for Clinical Vaccinology and Tropical Medicine and will be followed for a period of 6 months. The study is funded by the UK innovation agency - Innovate UK and the Department of Health.\n\n
REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0004
Date of REC Opinion
14 Feb 2018
REC opinion
Favourable Opinion