drugset / Trial / NCT03590392
Safety and Immunogenicity of a Candidate CHIKV Vaccine (CHIK001)
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-07-31
- Primary completion
- 2019-09-30
- Completion
- 2019-09-30
Outcome
Met primary endpoint
paper ChAdOx1 Chik was safe at all doses tested with no serious adverse reactions reported. PMID 34330906 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ChAdOx1 Chik | Vaccine | 5e+09 unknown | Intramuscular |
| Subject | ChAdOx1 Chik | Vaccine | 2.5e+10 unknown | Intramuscular |
| Subject | ChAdOx1 Chik | Vaccine | 5e+10 unknown | Intramuscular |