Status:
COMPLETED
Safety and Immunogenicity of CJ-50300
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
HK inno.N Corporation
Conditions:
Smallpox
Eligibility:
All Genders
20-28 years
Phase:
PHASE1
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 is urgently needed because p...
Eligibility Criteria
Inclusion
- Healthy Korean male and female subjects between 20 and 28 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
- 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).
- 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 with inflammatory ophthalmic disease requiring steroid 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 and steroid within 14 days of vaccination
- Receipt of investigational research agents within 120 days of vaccination
- HBsAg seropositive
- HCV antibody seropositive
- HIV seropositive
- Subjects having fever (oral temperature \> 38℃) or severe nutrition disorder
- Blood donation within 12 weeks in advance screening visit
- Subject who are not suitable to participate in study according to invesigator's judgement
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00336635
Start Date
June 1 2006
End Date
February 1 2007
Last Update
April 19 2007
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea, 110-744