NCT03590392

Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Chikungunya Fever

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1 Chik	ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.

Timeline

• Start date: 2018-07-31
• Primary completion: 2019-09-30
• Completion: 2019-09-30
• First posted: 2018-07-18
• Last updated: 2019-10-18

Locations

1 site across 1 country: United Kingdom