NCT04754776

Safety and Immunogenicity of a Candidate RVFV Vaccine (RVF001)

A Phase I Study to Determine the Safety & Immunogenicity of the Candidate Rift Valley Fever Virus (RVFV) Vaccine ChAdOx1 RVF in UK Healthy Adult Volunteers

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Phase I open label, non-randomised dose escalation study on healthy UK volunteers aged from 18 to 50 years to assess the safety and immunogenicity of ChAdOx1 RVF

Detailed description

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, however no licensed vaccines or specific treatments are currently available for humans. The study will enable assessment of the safety of the new vaccine called ChAdOx1 RVF and the extent of immune response in healthy volunteers. 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.

Conditions

• Rift Valley Fever

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 RVF	Single dose of ChAdOx1 RVF

Timeline

• Start date: 2021-06-11
• Primary completion: 2022-04-06
• Completion: 2022-04-06
• First posted: 2021-02-15
• Last updated: 2023-05-19

Locations

1 site across 1 country: United Kingdom