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Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers

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. Identifier: NCT01056770
Recruitment Status : Completed
First Posted : January 26, 2010
Last Update Posted : December 6, 2013
HK inno.N Corporation
Information provided by (Responsible Party):
Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE January 24, 2010
First Posted Date  ICMJE January 26, 2010
Last Update Posted Date December 6, 2013
Study Start Date  ICMJE October 2009
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2010)
  • Pocket formation [ Time Frame: 7-9 day ]
  • Adverse reactions [ Time Frame: 0-28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2010)
Antibody response [ Time Frame: 14 or 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers
Official Title  ICMJE An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Vaccinia-naive Healthy Volunteers
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Smallpox
Intervention  ICMJE Drug: smallpox vaccine CJ-50300
Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Other Name: CJ-53300
Study Arms  ICMJE Experimental: Vaccinia-naive group
2.5 * 10^5 pfu/dose
Intervention: Drug: smallpox vaccine CJ-50300
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2010)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy Korean male and female subjects between 19 and 60 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. Subjects who have been vaccinated with smallpox vaccines
  2. 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, basal cell carcinoma, liver cirrhosis or advanced liver disease).
  3. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
  4. History or present of eczema or atopic dermatitis
  5. Allergy or sensitivity to any known components of vaccine or other medicines
  6. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
  7. Subjects who have taken corticosteroid within 3 months of vaccination or who are taking oral or parenteral corticosteroid.
  8. Subjects who have been taken immunosuppressive therapy including interferon within 3 months of vaccination or are taking immunosuppressive therapy.
  9. Subjects who are planning for blood donations
  10. Autoimmune disease such as lupus erythematosus
  11. Subjects who work in medical institution
  12. Household contacts with women who are pregnant or breast-feeding
  13. 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
  14. Subjects household member < 1 year old or work with children < 1 year old
  15. 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
  16. Receipt of immunoglobulin or vaccine within 4 weeks of vaccination
  17. Subjects who are allergic to latex, inflammatory opthalmic disease, or taking antiviral agents.
  18. Receipt of investigational research agents within 4 months of vaccination
  19. HBsAg seropositive
  20. HCV antibody seropositive
  21. HIV seropositive
  22. Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  23. Blood donation within 3 months since screening visit
  24. Subject who are not suitable to participate in study according to investigator's judgement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01056770
Other Study ID Numbers  ICMJE CJ_SPX_302
CJ corporation ( Other Identifier: Cheiljedang Corporation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE HK inno.N Corporation
Investigators  ICMJE
Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date December 2013

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