This is a phase II randomised, open-label study to assess the safety and immunogenicity of coadministration of the candidate rabies vaccine ChAdOx2 RabG and licensed vaccine in healthy adults (18-45 years old). ChAdOx2 RabG will be administered intramuscularly and licensed rabies vaccine will be given either intramuscularly (i.e., for the intervention group) or by intradermal injection (i.e., for the control group).
A total of 40 participants will be recruited into 2 groups in Bagamoyo, Tanzania. The duration of the study will be up to 56 days per participant from the time of first vaccination. Participants in the intervention group will receive coadministration of ChAdOx2 RabG and licensed inactivated rabies vaccine (IRV) at a single visit, while participants in the control group will receive only licenced rabies vaccine at 3 visits. Participant groups who will receive coadministration of ChAdOx2 RabG and licensed rabies vaccine will also receive a 1-site IM vaccination with IRV on day 56.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A single visit of coadministration of 5×10\^10 vp ChAdOx2 RabG (2 site IM) and licensed IRV (2 site IM).
A World Health Organization (WHO) prequalified IRV at two anatomical sites (2 site ID) on days 0, 3 and 7.
Ifakara Health Institute
Bagamoyo, Tanzania
Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of solicited adverse events.
Occurrence of local and systemic solicited AEs
Time frame: Assessment of solicited AEs in the first 7 days post vaccination
Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of unsolicited adverse events.
Occurrence of unsolicited local and systemic adverse events
Time frame: Unsolicited AEs to be assessed up to 28 days post vaccination
Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of laboratory adverse events.
Occurrence of laboratory adverse events.
Time frame: Clinical laboratory AEs to be assessed up to 28 days post vaccination.
Safety and tolerability of coadministration of ChAdOx2 RabG and inactivated rabies vaccine (IRV) in healthy adults (18-45 years) residing in a rabies endemic country by the occurrence of serious adverse events.
Occurrence of serious adverse events
Time frame: SAEs will be collected from enrolment until the end of the follow-up period (Day 56).
A comparison of the immunogenicity of a singe-visit IM coadministration of ChAdOx2 RabG and licensed IRV versus three-visit ID administration of licensed IRV.
Rabies virus neutralising antibody (VNA) will be assessed by rapid fluorescent focus inhibition test (RFFIT).
Time frame: Rabies virus neutralisation antibody titres will be determined at baseline and days 7, 14, 21, 28, and 56.
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