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

NCT ID: NCT01317238

Last Updated: 2013-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2011-12-31

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 in previously vaccinated healthy volunteers

Conditions

Smallpox

Keywords

Smallpox vaccine efficacy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CJ Vaccination arm

healthy vaccinia-experienced volunteers who received CJ smallpox vaccine

Group Type: EXPERIMENTAL

smallpox vaccine CJ-50300

Intervention Type: DRUG

Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Interventions

smallpox vaccine CJ-50300

Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Intervention Type: DRUG

Other Intervention Names

CJ-53300

Eligibility 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

• Minimum Eligible Age: 32 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

Responsibility Role: SPONSOR

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

Other Identifiers

CJ corporation

Identifier Type: -

Identifier Source: secondary_id

CJ_SPX_303

Identifier Type: -

Identifier Source: org_study_id