Safety and Efficacy of CJ-50300 in Healthy Volunteers

Seoul National University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Smallpox

Treatments

Biological: smallpox vaccine CJ-50300

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00607243

CJ corporation (Other Identifier)

CJ_SPX_301

Details and patient eligibility

About

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.

Enrollment

123 patients

Sex

All

Ages

20 to 60 years old

Volunteers

Accepts Healthy Volunteers

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