Smallpox
Conditions
Keywords
Smallpox vaccine efficacy
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.
Interventions
BIOLOGICALsmallpox vaccine CJ-50300
Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
Sponsors
HK inno.N Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy Korean male and female subjects between 20 and 60 years of age at the time of screening visit 2. Willing to participate and have signed the informed consent form 3. In good general health, without clinically skin diseases history, physical examination or laboratory test results 4. Hematocrit \> 33% for women; \> 38% for men 5. White cell count 3,300-12,000/mm3 6. Total lymphocyte count \> 800 cells/mm3 7. Subjects who have never been vaccinated with smallpox vaccines
Exclusion criteria
1. 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). 2. In close physical contact (household or at work) with an individual who has the diseases or conditions that cause immunodeficiency 3. History or present of eczema or atopic dermatitis 4. Allergy or sensitivity to any known components of vaccine or other medicines 5. In close physical contact (household or at work) with an individual who has acute or chronic skin conditions such as dermatitis, exfoliative dermatitis 6. Subjects requiring steroid therapy 7. Subjects who are taking immunosuppressive therapy 8. Subjects who are planning for blood donations 9. Autoimmune disease such as lupus erythematosus 10. Subjects who work in medical institution 11. Household contacts with women who are pregnant or breast-feeding 12. 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 13. Subjects household member \< 1 year old or work with children \< 1 year old 14. 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 15. Receipt of immunoglobulin and steroid within 14 days of vaccination 16. Receipt of investigational research agents within 120 days of vaccination 17. HBsAg seropositive 18. HCV antibody seropositive 19. HIV seropositive 20. Subjects having fever (oral temperature \> 38℃) or severe nutrition disorder 21. Blood donation within 12 weeks in advance screening visit 22. Subject who are not suitable to participate in study according to investigator's judgement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cutaneous Take Reaction | 7-9 day | The take reactionwas defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken. |
| Adverse Reactions | 0-28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody Response | 14 or 28 days |
| Cell-mediate Immunity | 14 or 28 days |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Conventional-dose Group Conventional CJ-50300 2.5 x 100000pfu/dose vaccination | 82 |
| Low-dose Group Diluted CJ-50300 2.5 x 10000pfu/dose vaccination | 41 |
| Total | 123 |
Baseline characteristics
| Characteristic | Low-dose Group | Conventional-dose Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 82 Participants | 123 Participants |
| Age Continuous | 24.3 years STANDARD_DEVIATION 2.8 | 23.9 years STANDARD_DEVIATION 2.1 | 24.0 years STANDARD_DEVIATION 2.7 |
| Region of Enrollment Korea, Republic of | 41 participants | 82 participants | 123 participants |
| Sex: Female, Male Female | 13 Participants | 21 Participants | 34 Participants |
| Sex: Female, Male Male | 28 Participants | 61 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 28 / 82 | 15 / 41 |
| serious Total, serious adverse events | 0 / 82 | 0 / 41 |
Outcome results
Primary
Adverse Reactions
Time frame: 0-28 days
Primary
Cutaneous Take Reaction
The take reactionwas defined as a vesicular or pustular lesion or an area of definite palpable induration or congestion surrounding a central lesion (a crust or ulcer) occurring at the vaccination site at any of post-vaccination days (PVDs) 6-8. The vaccination site was photographed, and measures were taken.
Time frame: 7-9 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Conventional-dose Group | Cutaneous Take Reaction | 81 participants |
| Low-dose Group | Cutaneous Take Reaction | 41 participants |
Secondary
Antibody Response
Time frame: 14 or 28 days
Secondary
Cell-mediate Immunity
Time frame: 14 or 28 days