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