Safety and Immunogenicity of CJ-50300

This study has been completed.
Sponsor:
Collaborator:
CJ HealthCare 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
  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:

Primary Outcome Measures:
  • safety and immunogenicity

Estimated Enrollment: 24
Study Start Date: June 2006
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   20 Years to 28 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Korean male and female subjects between 20 and 28 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. 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).
  2. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
  3. history or present of eczema or atopic dermatitis
  4. Allergy or sensitivity to any known components of vaccine or other medicines
  5. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
  6. Subjects with inflammatory ophthalmic disease requiring steroid therapy
  7. Subjects who are planning for blood donations
  8. Autoimmune disease such as lupus erythematosus
  9. Subjects who work in medical institution
  10. Household contacts with women who are pregnant or breast-feeding
  11. 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
  12. Subjects household member <1 year old or work with children <1 year old
  13. 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
  14. Receipt of immunoglobulin and steroid within 14 days of vaccination
  15. Receipt of investigational research agents within 120 days of vaccination
  16. HBsAg seropositive
  17. HCV antibody seropositive
  18. HIV seropositive
  19. Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  20. Blood donation within 12 weeks in advance screening visit
  21. Subject who are not suitable to participate in study according to invesigator’s judgement
  Contacts and Locations
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, see Learn About Clinical Studies.

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 HealthCare 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 August 20, 2014