Ignite Creation Date:
2025-12-24 @ 3:31 PM
Ignite Modification Date:
2025-12-27 @ 5:44 AM
Study NCT ID:
NCT03590392
Status:
COMPLETED
Last Update Posted:
2019-10-18
First Post:
2018-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Chikungunya Virus (CHIKV) Vaccine ChAdOx1 Chik in Healthy Adult Volunteers
Status:
COMPLETED
Status Verified Date:
2019-07
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:
A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccine ChAdOx1 Chik in healthy volunteers.
Volunteers will be recruited and vaccinated in Oxford, England.
All vaccinations will be administered intramuscularly. Three different doses will be tested (5x10\^9 vp, 2.5x10\^10 vp and 5x10\^10vp).
The total duration of the study will be 26 weeks from the day of enrolment for all volunteers.
Volunteers will be recruited and vaccinated in Oxford, England.
All vaccinations will be administered intramuscularly. Three different doses will be tested (5x10\^9 vp, 2.5x10\^10 vp and 5x10\^10vp).
The total duration of the study will be 26 weeks from the day of enrolment for all volunteers.
Detailed Description:
This is a phase I, open label, dose escalation trial to assess the safety and immunogenicity of the ChAdOx1 Chik vaccine in healthy volunteers
There will be 3 study groups with a total of 24 volunteers. ChAdOx1 Chik will be administered intramuscularly as a single vaccination at 3 different doses: 5x10\^9 vp (group 1), 2.5x10\^10 (group 2) and 5x10\^10 vp (group 3)
Vaccination of groups will be sequential from Group 1 to Group 3 with interim safety reviews prior to dose escalation
Volunteers will be recruited and undergo screening, vaccination and follow-up visits at the trial site. Blood samples for safety and immunology purposes will be performed on the visit time points indicated in the schedule of attendances.
Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study.
Immune responses will be assessed pre and post vaccination procedure at different time points throughout the trial
There will be 3 study groups with a total of 24 volunteers. ChAdOx1 Chik will be administered intramuscularly as a single vaccination at 3 different doses: 5x10\^9 vp (group 1), 2.5x10\^10 (group 2) and 5x10\^10 vp (group 3)
Vaccination of groups will be sequential from Group 1 to Group 3 with interim safety reviews prior to dose escalation
Volunteers will be recruited and undergo screening, vaccination and follow-up visits at the trial site. Blood samples for safety and immunology purposes will be performed on the visit time points indicated in the schedule of attendances.
Safety will be assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study.
Immune responses will be assessed pre and post vaccination procedure at different time points throughout the trial
Study Oversight
Has Oversight DMC:
None
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?: