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Safety and Immunogenicity of CJ-50300

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cell-culture derived smallpox vaccine
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring smallpox, vaccine, immunity

Eligibility Criteria

20 Years - 28 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy Korean male and female subjects between 20 and 28 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 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 with inflammatory ophthalmic disease requiring steroid 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 invesigator's judgement

Sites / Locations

  • Seoul National University Hospital

Outcomes

Primary Outcome Measures

safety and immunogenicity

Secondary Outcome Measures

Full Information

First Posted
June 13, 2006
Last Updated
April 17, 2007
Sponsor
Seoul National University Hospital
Collaborators
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00336635
Brief Title
Safety and Immunogenicity of CJ-50300
Official Title
Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
HK inno.N Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 is 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 phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
Keywords
smallpox, vaccine, immunity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
cell-culture derived smallpox vaccine
Primary Outcome Measure Information:
Title
safety and immunogenicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Korean male and female subjects between 20 and 28 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 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 with inflammatory ophthalmic disease requiring steroid 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 invesigator's judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myoung-don Oh, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
17597266
Citation
Kim SH, Choi SJ, Park WB, Kim HB, Kim NJ, Oh MD, Choe KW. Detailed kinetics of immune responses to a new cell culture-derived smallpox vaccine in vaccinia-naive adults. Vaccine. 2007 Aug 14;25(33):6287-91. doi: 10.1016/j.vaccine.2007.05.044. Epub 2007 Jun 11.
Results Reference
derived

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Safety and Immunogenicity of CJ-50300

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