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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

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.

Condition or disease Intervention/treatment Phase
Smallpox Drug: smallpox vaccine CJ-50300 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Vaccinia-naive Healthy Volunteers
Study Start Date : October 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smallpox

Arm Intervention/treatment
Experimental: Vaccinia-naive group
2.5 * 10^5 pfu/dose
Drug: smallpox vaccine CJ-50300
Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Other Name: CJ-53300

Primary Outcome Measures :
  1. Pocket formation [ Time Frame: 7-9 day ]
  2. Adverse reactions [ Time Frame: 0-28 days ]

Secondary Outcome Measures :
  1. Antibody response [ Time Frame: 14 or 28 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01056770

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
HK inno.N Corporation
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Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital
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Responsible Party: Seoul National University Hospital Identifier: NCT01056770    
Other Study ID Numbers: CJ_SPX_302
CJ corporation ( Other Identifier: Cheiljedang Corporation )
First Posted: January 26, 2010    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by Seoul National University Hospital:
Smallpox vaccine efficacy
Additional relevant MeSH terms:
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Poxviridae Infections
DNA Virus Infections
Virus Diseases