Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers

This study has been completed.
Sponsor:
Collaborator:
CJ HealthCare Corporation
Information provided by (Responsible Party):
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01317238
First received: March 15, 2011
Last updated: May 30, 2013
Last verified: May 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 in previously vaccinated healthy volunteers


Condition Intervention Phase
Smallpox
Drug: smallpox vaccine CJ-50300
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Pocket formation [ Time Frame: 7-9 day ] [ Designated as safety issue: No ]
  • 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 ]

Enrollment: 145
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CJ Vaccination arm
healthy vaccinia-experienced volunteers who received CJ smallpox vaccine
Drug: smallpox vaccine CJ-50300
Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Other Name: CJ-53300

  Eligibility

Ages Eligible for Study:   32 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Korean male and female subjects below 60 years of age and born before 1979.
  2. subjects who have been vaccinated wiht smallpox vaccines
  3. Willing to participate and have signed the informed consent form
  4. In good general health, without clinically skin diseases history, physical examination or laboratory test results
  5. Hematocrit > 33% for women; > 38% for men
  6. White cell count 3,300-12,000/mm3
  7. Total lymphocyte count > 800 cells/mm3

Exclusion Criteria:

  1. Subjects who were born after 1980
  2. 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).
  3. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
  4. History or present of eczema or atopic dermatitis
  5. Allergy or sensitivity to any known components of vaccine or other medicines
  6. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
  7. Subjects who have taken corticosteroid within 3 months of vaccination or who are taking oral or parenteral corticosteroid.
  8. Subjects who have been taken immunosuppressive therapy including interferon within 3 months of vaccination or are taking immunosuppressive therapy.
  9. subjects who are planning for blood donations
  10. Autoimmune disease such as lupus erythematosus
  11. Subjects who work in medical institution
  12. Household contacts with women who are pregnant or breast-feeding
  13. 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
  14. Subjects household member < 1 year old or work with children < 1 year old
  15. 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
  16. Receipt of immunoglobulin or vaccine within 4 weeks of vaccination
  17. Subjects who are allergic to latex, inflammatory opthalmic disease, or taking antiviral agents.
  18. Receipt of investigational research agents within 4 months of vaccination
  19. HBsAg seropositive
  20. HCV antibody seropositive
  21. HIV seropositive
  22. Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  23. Blood donation within 3 months since screening visit
  24. 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: NCT01317238

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
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: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01317238     History of Changes
Other Study ID Numbers: CJ_SPX_303, CJ corporation
Study First Received: March 15, 2011
Last Updated: May 30, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Smallpox vaccine efficacy

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

ClinicalTrials.gov processed this record on August 28, 2014