drugset / Trial / NCT01056770

Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers

NCT01056770 ↗

NaSingle-groupOpen-labelPrevention

Summary

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 are 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 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

Timeline

Start
2009-10
Primary completion
2010-12
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject CJ-50300 Vaccine 250000 unknown —

Indications