Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT07168018
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
A Phase II Randomised, Open-label Study of the Safety and Immunogenicity of Coadministration of the Candidate Rabies Vaccine ChAdOx2 RabG and Licensed Vaccine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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).
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: