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Safety and Efficacy of CJ-50300 in Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
CJ HealthCare Corporation
Information provided by (Responsible Party):
Myoung-don Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00607243
First received: January 31, 2008
Last updated: July 7, 2013
Last verified: July 2013
  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 are 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 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.


Condition Intervention Phase
Smallpox
Biological: smallpox vaccine CJ-50300
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Double Blind, a Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CJ-50300 in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Cutaneous Take Reaction [ Time Frame: 7-9 day ] [ Designated as safety issue: No ]
    The "take reaction"was defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken.

  • Adverse Reactions [ Time Frame: 0-28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Antibody Response [ Time Frame: 14 or 28 days ] [ Designated as safety issue: No ]
  • Cell-mediate Immunity [ Time Frame: 14 or 28 days ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conventional dose group
Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Biological: smallpox vaccine CJ-50300
Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
Other Name: CJ-53300
Experimental: Low dose group
Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
Biological: smallpox vaccine CJ-50300
Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
Other Name: CJ-53300

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Korean male and female subjects between 20 and 60 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
  7. Subjects who have never been vaccinated with smallpox vaccines

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 requiring steroid therapy
  7. Subjects who are taking immunosuppressive therapy
  8. Subjects who are planning for blood donations
  9. Autoimmune disease such as lupus erythematosus
  10. Subjects who work in medical institution
  11. Household contacts with women who are pregnant or breast-feeding
  12. 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
  13. Subjects household member < 1 year old or work with children < 1 year old
  14. 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
  15. Receipt of immunoglobulin and steroid within 14 days of vaccination
  16. Receipt of investigational research agents within 120 days of vaccination
  17. HBsAg seropositive
  18. HCV antibody seropositive
  19. HIV seropositive
  20. Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  21. Blood donation within 12 weeks in advance screening visit
  22. Subject who are not suitable to participate in study according to investigator'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: NCT00607243

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
Principal Investigator: Myoung-don Oh, M.D. Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Myoung-don Oh, Professor, Division of Infectious Diseases, Department of Internal Medicine, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00607243     History of Changes
Other Study ID Numbers: CJ_SPX_301, CJ corporation
Study First Received: January 31, 2008
Results First Received: August 2, 2011
Last Updated: July 7, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Smallpox vaccine efficacy

Additional relevant MeSH terms:
Smallpox
DNA Virus Infections
Poxviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014