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Safety and Immunogenicity of CJ-50300

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00336635
First Posted: June 14, 2006
Last Update Posted: April 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CJ HealthCare Corporation
Information provided by:
Seoul National University Hospital
June 13, 2006
June 14, 2006
April 19, 2007
June 2006
Not Provided
safety and immunogenicity
Same as current
Complete list of historical versions of study NCT00336635 on ClinicalTrials.gov Archive Site
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Safety and Immunogenicity of CJ-50300
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Smallpox
Biological: cell-culture derived smallpox vaccine
Not Provided
Kim SH, Choi SJ, Park WB, Kim HB, Kim NJ, Oh MD, Choe KW. Detailed kinetics of immune responses to a new cell culture-derived smallpox vaccine in vaccinia-naïve adults. Vaccine. 2007 Aug 14;25(33):6287-91. Epub 2007 Jun 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
February 2007
Not Provided

Inclusion Criteria:

  1. Healthy Korean male and female subjects between 20 and 28 years of age at the time of screening visit.
  2. Willing to participate and have signed the informed consent form
  3. In good general health, without clinically skin diseases history, physical examination or laboratory test results
  4. Hematocrit >33% for women; >38% for men
  5. White cell count 3,300-12,000/mm3
  6. Total lymphocyte count > 800 cells/mm3

Exclusion Criteria:

  1. Diseases or conditions that cause immunodeficiency (For examples; HIV AIDS, leukemia, lymphoma, generalized malignancy, agammaglobulinemia, history of transplantation, therapy with alkylating agents, antimetabolites, radiation, or oral or parenteral corticosteroids).
  2. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
  3. history or present of eczema or atopic dermatitis
  4. Allergy or sensitivity to any known components of vaccine or other medicines
  5. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
  6. Subjects with inflammatory ophthalmic disease requiring steroid therapy
  7. Subjects who are planning for blood donations
  8. Autoimmune disease such as lupus erythematosus
  9. Subjects who work in medical institution
  10. Household contacts with women who are pregnant or breast-feeding
  11. Female Subjects who are pregnant or breast-feeding and have positive result by serum pregnancy test or urine pregnancy test, or do not using approved contraceptives such as sterilization, contraceptive ring injectable, combined oral contraceptive pills and barrier contraceptive, combined hormone-based therapy, contraceptive cream, contraceptive jelly, diaphragm or condoms
  12. Subjects household member <1 year old or work with children <1 year old
  13. Subjects with a known history of Cardiac disease or have three or more of the following risk factors: hyperpiesia, obesity, hyperlipidemia, glucosuria, sclerosis, cerebral arteriosclerosis
  14. Receipt of immunoglobulin and steroid within 14 days of vaccination
  15. Receipt of investigational research agents within 120 days of vaccination
  16. HBsAg seropositive
  17. HCV antibody seropositive
  18. HIV seropositive
  19. Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  20. Blood donation within 12 weeks in advance screening visit
  21. Subject who are not suitable to participate in study according to invesigator’s judgement
Sexes Eligible for Study: All
20 Years to 28 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00336635
CJ_SPX_101
Yes
Not Provided
Not Provided
Not Provided
Seoul National University Hospital
CJ HealthCare Corporation
Study Chair: Myoung-don Oh, MD Seoul National University Hospital
Seoul National University Hospital
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP