Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers - Full Text View

Purpose

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

Condition	Intervention	Phase
Smallpox	Drug: smallpox vaccine CJ-50300	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Smallpox

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Pocket formation [ Time Frame: 7-9 day ] [ Designated as safety issue: No ]
Adverse reactions [ Time Frame: 0-28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Antibody response [ Time Frame: 14 or 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	145
Study Start Date:	October 2010
Estimated Study Completion Date:	December 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination

Other Name: CJ-53300

Eligibility

Ages Eligible for Study:	32 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317238

Locations

Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

CJ Cheiljedang Corporation

Investigators

Principal Investigator:

Myoung-don Oh, M.D

Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Myoung-don Oh, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT01317238 History of Changes
Other Study ID Numbers:	CJ_SPX_303, CJ corporation
Study First Received:	March 15, 2011
Last Updated:	August 2, 2011
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

Smallpox vaccine efficacy

Additional relevant MeSH terms:

Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013