Safety and Efficacy of CJ-50300 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Smallpox
• Intervention / Treatment: Biological: smallpox vaccine CJ-50300

• Study Type: Interventional
• Enrollment (Actual): 123
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Conventional dose group; Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination	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; Other Names: CJ-53300
EXPERIMENTAL: Low dose group; Diluted CJ-50300 2.5 x 10000pfu/dose vaccination	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; Other Names: CJ-53300

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Adverse Reactions		0-28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Antibody Response	14 or 28 days
Cell-mediate Immunity	14 or 28 days

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: HK inno.N Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): June 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: January 31, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (ESTIMATE): February 5, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): July 9, 2013
• Last Update Submitted That Met QC Criteria: July 7, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Smallpox vaccine efficacy
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Smallpox
• Other Study ID Numbers: CJ_SPX_301; CJ corporation (OTHER: CJ corporation)