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Sponsors and Collaborators: |
Seoul National University Hospital CJ Corporation |
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Information provided by: | Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT00336635 |
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.
Condition | Intervention | Phase |
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Smallpox |
Biological: cell-culture derived smallpox vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
Official Title: | Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I |
Ages Eligible for Study: | 20 Years to 28 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Seoul National University Hospital | |
Seoul, Korea, Republic of, 110-744 |
Study Chair: | Myoung-don Oh, MD | Seoul National University Hospital |
Study ID Numbers: | CJ_SPX_101 |
Study First Received: | June 13, 2006 |
Last Updated: | April 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00336635 |
Health Authority: | Korea: Food and Drug Administration |
smallpox, vaccine, immunity |
Virus Diseases Smallpox Poxviridae Infections DNA Virus Infections Healthy |