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Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers

Primary Purpose

Smallpox

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
smallpox vaccine CJ-50300
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring Smallpox vaccine efficacy

Eligibility Criteria

32 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy Korean male and female subjects below 60 years of age and born before 1979.
  2. subjects who have been vaccinated wiht smallpox vaccines
  3. Willing to participate and have signed the informed consent form
  4. In good general health, without clinically skin diseases history, physical examination or laboratory test results
  5. Hematocrit > 33% for women; > 38% for men
  6. White cell count 3,300-12,000/mm3
  7. Total lymphocyte count > 800 cells/mm3

Exclusion Criteria:

  1. Subjects who were born after 1980
  2. 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).
  3. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency
  4. History or present of eczema or atopic dermatitis
  5. Allergy or sensitivity to any known components of vaccine or other medicines
  6. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis
  7. Subjects who have taken corticosteroid within 3 months of vaccination or who are taking oral or parenteral corticosteroid.
  8. Subjects who have been taken immunosuppressive therapy including interferon within 3 months of vaccination or are taking immunosuppressive therapy.
  9. subjects who are planning for blood donations
  10. Autoimmune disease such as lupus erythematosus
  11. Subjects who work in medical institution
  12. Household contacts with women who are pregnant or breast-feeding
  13. 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
  14. Subjects household member < 1 year old or work with children < 1 year old
  15. 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
  16. Receipt of immunoglobulin or vaccine within 4 weeks of vaccination
  17. Subjects who are allergic to latex, inflammatory opthalmic disease, or taking antiviral agents.
  18. Receipt of investigational research agents within 4 months of vaccination
  19. HBsAg seropositive
  20. HCV antibody seropositive
  21. HIV seropositive
  22. Subjects having fever (oral temperature > 38℃) or severe nutrition disorder
  23. Blood donation within 3 months since screening visit
  24. 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

CJ Vaccination arm

Arm Description

healthy vaccinia-experienced volunteers who received CJ smallpox vaccine

Outcomes

Primary Outcome Measures

Pocket formation
Adverse reactions

Secondary Outcome Measures

Antibody response

Full Information

First Posted
March 15, 2011
Last Updated
May 30, 2013
Sponsor
Seoul National University Hospital
Collaborators
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01317238
Brief Title
Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers
Official Title
An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 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 in previously vaccinated healthy volunteers

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
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CJ Vaccination arm
Arm Type
Experimental
Arm Description
healthy vaccinia-experienced volunteers who received CJ smallpox vaccine
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
32 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy Korean male and female subjects below 60 years of age and born before 1979. subjects who have been vaccinated wiht smallpox vaccines 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 were born after 1980 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
Country
Korea, Republic of

12. IPD Sharing Statement

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Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers

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