Safety and Efficacy of CJ-50300 in Healthy Volunteers

Smallpox Clinical Trial

Official title:

Randomized, Double Blind, a Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CJ-50300 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607243
• Other study ID #: CJ_SPX_301
• Secondary ID: CJ corporation
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 31, 2008
• Last updated: July 7, 2013
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: July 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: 123
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smallpox

Intervention

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

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	Cutaneous Take Reaction	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.	7-9 day	No
Primary	Adverse Reactions		0-28 days	Yes
Secondary	Antibody Response		14 or 28 days	No
Secondary	Cell-mediate Immunity		14 or 28 days	No