Safety and Immunogenicity of a candidate RVFV vaccine (RVF001)
Research type
Research Study
Full title
A phase I study to determine the safety and immunogenicity of the candidate Rift Valley Fever Virus (RVFV) vaccine ChAdOx1 RVF in UK healthy adult volunteers
IRAS ID
246707
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance (CTRG).
Eudract number
2017-004482-27
Duration of Study in the UK
0 years, 6 months, 10 days
Research summary
The purpose of this study is to test a new vaccine against the Rift Valley Fever Virus (RVFV) in healthy volunteers.
Rift Valley fever is a disease caused by RVFV and it is transmitted to humans through a mosquito bite or contact with virus-contaminated tissues and fluids. Although initially restricted to Africa, the virus can be transmitted by several different mosquito species that are more widely distributed than the virus itself, leading to concerns of disease spread as has occurred in the Arabian Peninsula and Madagascar. In humans, RVFV infection usually presents as a sudden febrile illness, but severe manifestations including bleeding disorders and neurological complications may also occur. RVFV is considered a global health threat with significant potential for international spread and use in bioterrorism.
Vaccines against RVFV are available for livestock, but no licensed vaccines or specific treatments are currently available for humans.
The study will enable us to assess the safety of the new vaccine called ChAdOx1 RVF 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.
Healthy 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 3 months. The study is funded by the UK Biotechnology and Biological Sciences Research Council(BBSRC) and the Medical Research Council (MRC)/Department of Health, through the UK Vaccines Network.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0262
Date of REC Opinion
22 Dec 2020
REC opinion
Further Information Favourable Opinion