NCT05301504

A Study in Tanzania of a New Vaccine Against Two Types of Ebola

A Phase Ib Study to Determine the Safety and Immunogenicity of a Bivalent ChAdOx1 Vectored Vaccine Against Zaire and Sudan Ebola Virus Species in Tanzanian Healthy Adult Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial

Detailed description

This is an open label, first in human, dose escalation, phase Ib clinical trial to assess the safety and immunogenicity of the candidate ChAdOx1 biEBOV vaccine in healthy Tanzanian volunteers aged 18-45. The vaccine will be administered intramuscularly (IM). There will be 4 study groups and it is anticipated that a total of 76 volunteers will be enrolled. Dose escalation and sentinel participant procedures will be implemented. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers will be sequentially allocated to a study group by selecting eligible volunteers for enrolment following screening. Sequential allocation will occur based on the order in which volunteers are enrolled. Group 4 will be recruited last, with dose selection being dependent on completion of groups 1-3 and a review of safety data. The trial is funded by Innovate UK project reference 971615.

Conditions

• Ebola

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 biEBOV	ChAdOx1 biEBOV is provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)

Timeline

• Start date: 2022-03-30
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-03-29
• Last updated: 2023-02-08

Locations

1 site across 1 country: Tanzania