Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers

Inclusion criteria

• Healthy Korean male and female subjects between 19 and 60 years of age at the time of screening visit
• Willing to participate and have signed the informed consent form
• In good general health, without clinically skin diseases history, physical examination or laboratory test results
• Hematocrit > 33% for women; > 38% for men
• White cell count 3,300-12,000/mm3
• Total lymphocyte count > 800 cells/mm3

Exclusion criteria

• Subjects who have been vaccinated with smallpox vaccines
• 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).
• In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
• History or present of eczema or atopic dermatitis
• Allergy or sensitivity to any known components of vaccine or other medicines
• In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
• Subjects who have taken corticosteroid within 3 months of vaccination or who are taking oral or parenteral corticosteroid.
• Subjects who have been taken immunosuppressive therapy including interferon within 3 months of vaccination or are taking immunosuppressive therapy.
• Subjects who are planning for blood donations
• Autoimmune disease such as lupus erythematosus
• Subjects who work in medical institution
• Household contacts with women who are pregnant or breast-feeding
• 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
• Subjects household member < 1 year old or work with children < 1 year old
• 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
• Receipt of immunoglobulin or vaccine within 4 weeks of vaccination
• Subjects who are allergic to latex, inflammatory opthalmic disease, or taking antiviral agents.
• Receipt of investigational research agents within 4 months of vaccination
• HBsAg seropositive
• HCV antibody seropositive
• HIV seropositive
• Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
• Blood donation within 3 months since screening visit
• Subject who are not suitable to participate in study according to investigator's judgement