NCT01317238

Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers

An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 32 Years – 60 Years
• Healthy volunteers: Accepted

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 in previously vaccinated healthy volunteers

Conditions

• Smallpox

Interventions

Type	Name	Description
DRUG	smallpox vaccine CJ-50300	Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2011-03-17
• Last updated: 2013-05-31

Locations

1 site across 1 country: South Korea