Safety and Efficacy of CJ-50300 in Healthy Volunteers

Study Overview
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Brief Summary
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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.

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

Conditions
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Smallpox

Intervention / Treatment
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* Biological: smallpox vaccine CJ-50300


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Korean male and female subjects between 20 and 60 years of age at the time of screening visit Willing to participate and have signed the informed consent form In good general health, without clinically skin diseases history, physical examination or laboratory test results Hematocrit > 33% for women; > 38% for men White cell count 3,300-12,000/mm3 Total lymphocyte count > 800 cells/mm3 Subjects who have never been vaccinated with smallpox vaccines Exclusion Criteria: 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). In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency History or present of eczema or atopic dermatitis Allergy or sensitivity to any known components of vaccine or other medicines In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis Subjects requiring steroid therapy Subjects who are taking immunosuppressive therapy Subjects who are planning for blood donations Autoimmune disease such as lupus erythematosus Subjects who work in medical institution Household contacts with women who are pregnant or breast-feeding 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 Subjects household member < 1 year old or work with children < 1 year old 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 Receipt of immunoglobulin and steroid within 14 days of vaccination Receipt of investigational research agents within 120 days of vaccination HBsAg seropositive HCV antibody seropositive HIV seropositive Subjects having fever (oral temperature > 38℃) or severe nutrition disorder Blood donation within 12 weeks in advance screening visit Subject who are not suitable to participate in study according to investigator's judgement

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional dose group<br>Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination | Biological: smallpox vaccine CJ-50300<br>* Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose<br>* Other names: CJ-53300;|
| Experimental: Low dose group<br>Diluted CJ-50300 2.5 x 10000pfu/dose vaccination | Biological: smallpox vaccine CJ-50300<br>* Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose<br>* Other names: CJ-53300;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cutaneous Take Reaction | The take reactionwas 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Response |  | 14 or 28 days | 
| Cell-mediate Immunity |  | 14 or 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smallpox vaccine efficacy