Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers
Primary Purpose
Smallpox
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
smallpox vaccine CJ-50300
Sponsored by
About this trial
This is an interventional prevention trial for Smallpox focused on measuring Smallpox vaccine efficacy
Eligibility Criteria
Inclusion Criteria:
- Healthy Korean male and female subjects between 19 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
Exclusion Criteria:
- Subjects who have been vaccinated with smallpox vaccines
- 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).
- 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 who have taken corticosteroid within 3 months of vaccination or who are taking oral or parenteral corticosteroid.
- Subjects who have been taken immunosuppressive therapy including interferon within 3 months of vaccination or 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 or vaccine within 4 weeks of vaccination
- Subjects who are allergic to latex, inflammatory opthalmic disease, or taking antiviral agents.
- Receipt of investigational research agents within 4 months of vaccination
- HBsAg seropositive
- HCV antibody seropositive
- HIV seropositive
- Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
- Blood donation within 3 months since screening visit
- Subject who are not suitable to participate in study according to investigator's judgement
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccinia-naive group
Arm Description
2.5 * 10^5 pfu/dose
Outcomes
Primary Outcome Measures
Pocket formation
Adverse reactions
Secondary Outcome Measures
Antibody response
Full Information
NCT ID
NCT01056770
First Posted
January 24, 2010
Last Updated
December 5, 2013
Sponsor
Seoul National University Hospital
Collaborators
HK inno.N Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01056770
Brief Title
Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox
Keywords
Smallpox vaccine efficacy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vaccinia-naive group
Arm Type
Experimental
Arm Description
2.5 * 10^5 pfu/dose
Intervention Type
Drug
Intervention Name(s)
smallpox vaccine CJ-50300
Other Intervention Name(s)
CJ-53300
Intervention Description
Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Primary Outcome Measure Information:
Title
Pocket formation
Time Frame
7-9 day
Title
Adverse reactions
Time Frame
0-28 days
Secondary Outcome Measure Information:
Title
Antibody response
Time Frame
14 or 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Korean male and female subjects between 19 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
Exclusion Criteria:
Subjects who have been vaccinated with smallpox vaccines
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).
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 who have taken corticosteroid within 3 months of vaccination or who are taking oral or parenteral corticosteroid.
Subjects who have been taken immunosuppressive therapy including interferon within 3 months of vaccination or 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 or vaccine within 4 weeks of vaccination
Subjects who are allergic to latex, inflammatory opthalmic disease, or taking antiviral agents.
Receipt of investigational research agents within 4 months of vaccination
HBsAg seropositive
HCV antibody seropositive
HIV seropositive
Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
Blood donation within 3 months since screening visit
Subject who are not suitable to participate in study according to investigator's judgement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myoung-don Oh, M.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
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Safety and Efficacy of CJ Smallpox Vaccine in Healthy Volunteers
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