Project Title: A phase Ib study to determine the safety and immunogenicity of a bivalent ChAdOxl vectored vaccine against Zaire and Sudan Ebola virus species in Tanzania healthy adult volunteers
Project Description: This is an open-label, dose escalation, phase 1b 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 (1M). There will be 4 study groups and it is anticipated that a total of 76 volunteers will be enrolled. Volunteers will be first recruited into Group 1 and subsequently into Groups 2 and 3 following interim clinical safety reviews. Volunteers... This is an open-label, dose escalation, phase 1b 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 (1M). There will be 4 study groups and it is anticipated that a total of 76 volunteers will be enrolled. 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. paricip[ants will be recruited from around bagamoyo district. Research activities will be conducted by IHI research team based at Bagamoyo Clinical Trial Facility. The duration of the study will be 6months from the day of enrolment for each volunteer.
Principal Investigator : Ally Olotu
Department Name :
Time frame: (2021-08-01) - (2023-11-30)
The Chancellor Masters and University of Oxford (Normal)
External Collaborating Partners
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