Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers

Smallpox Clinical Trial

Official title:

An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Vaccinia-naive Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01056770
• Other study ID #: CJ_SPX_302
• Secondary ID: CJ corporation
• Status: Completed
• Phase: Phase 3
• First received: January 24, 2010
• Last updated: December 5, 2013
• Start date: October 2009
• Est. completion date: January 2011

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Healthy Korean male and female subjects between 19 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

Exclusion Criteria:

1. Subjects who have been vaccinated with smallpox vaccines

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smallpox

Intervention

Drug:
• smallpox vaccine CJ-50300
Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket formation		7-9 day	No
Primary	Adverse reactions		0-28 days	Yes
Secondary	Antibody response		14 or 28 days	No