An open label, first in human, non-randomised, dose escalation, single centre, phase Ib clinical trial
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
76
ChAdOx1 biEBOV is provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Bagamoyo Clinical Trial Facility
Bagamoyo, Tanzania
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of solicited local reactogenicity signs and symptoms
Time frame: 7 days following vaccination
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of solicited systemic reactogenicity signs and symptoms
Time frame: 7 days following vaccination
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of unsolicited adverse events (AEs)
Time frame: 28 days following vaccination
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of changes from baseline for safety laboratory measures
Time frame: Days 0, 2, 7, 28
Investigate the safety and tolerability of ChAdOx1 biEBOV in healthy volunteers.
Occurrence of SAEs and AESIs
Time frame: Whole duration of the study (~6 months)
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Filovirus GP specific serological response as measured by ELISA
Time frame: Days 0, 28, 56, 182
Investigate the immunogenicity of ChAdOx1 biEBOV in healthy adult volunteers.
Filovirus GP specific T cell response measured by IFN-γ ELISPOT
Time frame: Days 0, 7, 14, 28, 56, 128
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