Safety and Immunogenicity of CJ-50300
This study has been completed.
Sponsor:
Seoul National University Hospital
Collaborator:
CJ Cheiljedang Corporation
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00336635
First received: June 13, 2006
Last updated: April 17, 2007
Last verified: April 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 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 phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.
| Condition | Intervention | Phase |
|---|---|---|
|
Smallpox |
Biological: cell-culture derived smallpox vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I |
Resource links provided by NLM:
Further study details as provided by Seoul National University Hospital:
Eligibility| Ages Eligible for Study: | 20 Years to 28 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336635
Locations
| Korea, Republic of | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
Sponsors and Collaborators
Seoul National University Hospital
CJ Cheiljedang Corporation
Investigators
| Study Chair: | Myoung-don Oh, MD | Seoul National University Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00336635 History of Changes |
| Other Study ID Numbers: | CJ_SPX_101 |
| Study First Received: | June 13, 2006 |
| Last Updated: | April 17, 2007 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Hospital:
|
smallpox, vaccine, immunity |
Additional relevant MeSH terms:
|
Smallpox Poxviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on June 17, 2013