Safety and Efficacy of CJ-50300 in Healthy Volunteers

NCT ID: NCT00607243

Last Updated: 2013-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-12-31

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 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.

Conditions

Smallpox

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Conventional dose group

Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Group Type: EXPERIMENTAL

smallpox vaccine CJ-50300

Intervention Type: BIOLOGICAL

Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose

Low dose group

Diluted CJ-50300 2.5 x 10000pfu/dose vaccination

Group Type: EXPERIMENTAL

smallpox vaccine CJ-50300

Intervention Type: BIOLOGICAL

Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose

Interventions

smallpox vaccine CJ-50300

Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose

Intervention Type: BIOLOGICAL

Other Intervention Names

CJ-53300

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HK inno.N Corporation

INDUSTRY

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Myoung-don Oh

Professor, Division of Infectious Diseases, Department of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myoung-don Oh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

Jang HC, Kim CJ, Kim KH, Lee KH, Byun YH, Seong BL, Saletti G, Czerkinsky C, Park WB, Park SW, Kim HB, Kim NJ, Oh MD. A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers. Vaccine. 2010 Aug 16;28(36):5845-9. doi: 10.1016/j.vaccine.2010.06.063. Epub 2010 Jun 30.

Reference Type: DERIVED

PMID: 20600480 (View on PubMed)

Other Identifiers

CJ corporation

Identifier Type: OTHER

Identifier Source: secondary_id

CJ_SPX_301

Identifier Type: -

Identifier Source: org_study_id