Study design and participants
RVF, RECRUITMENT
We conducted a phase I, first-in-human, dose-escalation, open-label, non-randomised clinical trial of ChAdOx1 RVF vaccine at the Centre for Clinical Vaccinology and Tropical Medicine, Oxford, UK. Healthy adult volunteers aged 18-55 years were recruited from the local Oxfordshire area using ethically approved advertising materials. Potential volunteers initially completed an online questionnaire covering major exclusion criteria. They were then invited for an in-person screening visit where written informed consent for the study was obtained followed by a medical history assessment, physical examination, urinalysis, and clinical blood tests. Medical histories were corroborated using medical records obtained from the general practitioner (GP) of each volunteer prior to enrolment. Volunteers that had previously been vaccinated with a ChAdOx1 vaccine (e.g. ChAdOx1 nCoV-19) were excluded from the study. Additionally, volunteers with a history of travel to countries endemic for RVF were screened with a commercial RVF ELISA (ID Screen® Multispecies RVFV ELISA, ID.vet) as per manufacturer’s instructions and excluded if seropositive. Results of all screening assessments were reviewed by a trial investigator before enrolment or exclusion. Full eligibility criteria for the trial are detailed in the trial protocol (Supplementary Appendix).The trial was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice. Regulatory approval was granted by the UK Medicines and Healthcare Products Regulatory Agency (CTA 21584/0438/001-0001) and ethics approval by National Health Service (NHS) East of England – Cambridge East Research Ethics Committee (reference: 20/EE/0262). Use of ChAdOx1 RVF for this clinical trial was authorised by the Oxford University Hospital NHS Trust Genetic Modification Safety Committee (GM462.18.103). The trial was registered, prior to recruitment, at clinicaltrials.gov (NCT04754776).