Phase 3
N=123
Safety and Efficacy of CJ-50300 in Healthy Volunteers
Smallpox
Bottom Line
View on ClinicalTrials.gov: NCT00607243 ↗Enrolled (actual)
123
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: Cutaneous Take Reaction — 81; 41 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- smallpox vaccine CJ-50300 (Biological)
- Age
- Adult · 20+ yrs
- Sex
- All
- Sponsor
- Seoul National University Hospital
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cutaneous Take Reaction |
81; 41 | — |
| PRIMARY Adverse Reactions |
— | — |
| SECONDARY Antibody Response |
— | — |
| SECONDARY Cell-mediate Immunity |
— | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00607243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.