Clinical trial NCT01317238 (phase 3, status: completed)
Conditions: smallpox
ICD codes: B03, T50.B16S, T50.B13S, T50.B14S, T50.B15S, T50.B16A, T50.B16D
Drugs: smallpox vaccine cj-50300
SMILES: [O-][N+](=O)OCC(CO[N+]([O-])=O)(CO[N+]([O-])=O)CO[N+]([O-])=O
Eligibility criteria:

        Inclusion Criteria:

          1. Healthy Korean male and female subjects below 60 years of age and born before 1979.

          2. subjects who have been vaccinated wiht smallpox vaccines

          3. Willing to participate and have signed the informed consent form

          4. In good general health, without clinically skin diseases history, physical examination
             or laboratory test results

          5. Hematocrit > 33% for women; > 38% for men

          6. White cell count 3,300-12,000/mm3

          7. Total lymphocyte count > 800 cells/mm3

        Exclusion Criteria:

          1. Subjects who were born after 1980

          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