NCT04672824

A Study to Assess the New Candidate Rift Valley Fever Virus Vaccine in Healthy Adults

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Randomised, single blind, placebo - controlled, dose-escalation, phase I clinical trial recruiting healthy adults aged 18-50 years

Detailed description

This is a randomised, single blind, placebo-controlled, dose escalation, phase I clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 RVF vaccine in healthy Ugandan volunteers aged 18-50. The vaccine will be administered intramuscularly. This study will run concurrently with the first-in-human ChAdOx1 RVF trial in Oxford. Vaccination at the MRC/UVRI and LSHTM Uganda Research Unit, Masaka will only begin upon receiving a favourable opinion of Uganda's trial DSMB of the 7-day post-vaccination safety analysis of the first two lowest dose groups (ChAdOx1 RVF 5 x 10\^9vp and ChAdOx1 RVF 2.5 x 10\^10vp) of the trial in Oxford. Volunteers will be recruited and vaccinated at the MRC/UVRI and LSHTM Uganda Research Unit Clinical Research Centre in Masaka. There will be three study groups and a total of 30 volunteers will be enrolled (table 3). Volunteers will be recruited sequentially into Groups 1,2 and 3. Within each group, eligible volunteers will be randomly allocated to receive either ChAdOx1 RVF or placebo of 0.9% Normal Saline in a ratio of 2:1 in group 1 and 5:1 in groups 2 and 3. The DSMB will analyse the 7-day post-vaccination safety data in each group and advise on whether to proceed to the next group with a higher dose .

Conditions

• RVF
• Rift Valley Fever

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 RVF	Single dose ChAdOx1 vectored vaccine
OTHER	Saline	0.5ml saline placebo

Timeline

• Start date: 2022-05-31
• Primary completion: 2022-12-15
• Completion: 2022-12-15
• First posted: 2020-12-17
• Last updated: 2023-02-06

Locations

1 site across 1 country: Uganda