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Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I
The currently available stock of smallpox vaccine would be insufficient in the face of an incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine is urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by infecting MRC-5 cells. The aim of this phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.
Details
| Lead sponsor | Seoul National University Hospital |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 24 |
| Start date | 2006-06 |
| Completion | 2007-02 |
Conditions
- Smallpox
Interventions
- cell-culture derived smallpox vaccine
Primary outcomes
- safety and immunogenicity
Countries
South Korea