Smallpox Clinical Trial
Official title:
An Open-label, Single Arm, Phase III Clinical Study to Evaluate the Efficacy and Safety of CJ Smallpox Vaccine in Vaccinia-naive Healthy Volunteers
Verified date | December 2013 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 88 |
Est. completion date | January 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 19 Years to 60 Years |
Eligibility |
Inclusion Criteria: 1. Healthy Korean male and female subjects between 19 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 Exclusion Criteria: 1. Subjects who have been vaccinated with smallpox vaccines 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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | CJ HealthCare Corporation |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pocket formation | 7-9 day | No | |
Primary | Adverse reactions | 0-28 days | Yes | |
Secondary | Antibody response | 14 or 28 days | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05976100 -
Study of the Safety, Tolerability, Pharmacokinetics of NIOCH-14 in Volunteers Aged 18-50 Years
|
Phase 1 | |
Completed |
NCT01540929 -
Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel
|
||
Completed |
NCT00258947 -
Evaluation of Take and Safety of a Smallpox Vaccine in Healthy Young Adults
|
Phase 2 | |
Completed |
NCT00189969 -
Take Rate, Immunogenicity and Safety of Elstree-BN Smallpox Vaccine in Healthy Vaccinia-Naive Subjects
|
Phase 1 | |
Terminated |
NCT00053508 -
Dose Safety, Tolerability, and Immunogenicity of a New Smallpox Vaccine in Adults Without Previous Smallpox Vaccination
|
Phase 2 | |
Completed |
NCT01317238 -
Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers
|
Phase 3 | |
Terminated |
NCT00282581 -
Safety Study of MVA Smallpox Vaccine in HIV-positive Subjects Who Are Vaccinia Naive
|
Phase 1 | |
Withdrawn |
NCT00389103 -
Safety Study of MVA Smallpox Vaccine in Subjects With a History of Atopic Dermatitis (AD)
|
Phase 1 | |
Completed |
NCT00998543 -
A Long-Term Study of Healthy Adults Vaccinated With One Dose of Smallpox Vaccine (LISTER Strain)
|
Phase 2 | |
Completed |
NCT00133575 -
ACAM 3000 MVA at Harvard Medical School
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00103584 -
Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers
|
Phase 1/Phase 2 | |
Completed |
NCT00050505 -
Expanded Dryvax Dilution Study in Previously Vaccinated Adults
|
Phase 2 | |
Completed |
NCT05846243 -
Study on Immunogenicity, Reactogenicity and Safety of the VACΔ6 Vaccine in Volunteers Aged 18-60 Years
|
Phase 2/Phase 3 | |
Completed |
NCT05935917 -
Study Evaluating the Bioequivalence of Brincidofovir Form H and Form II Tablets in Healthy Adults
|
Phase 1 | |
Completed |
NCT00082446 -
Combination Study With MVA BN and Dryvax
|
Phase 1 | |
Completed |
NCT00038987 -
Vaccinia Virus Vaccine (APSV) in Vaccinia- Naive Subjects: PILOT
|
Phase 1/Phase 2 | |
Completed |
NCT05762523 -
Safety and Tolerability Study of the VAC∆6 Vaccine in Volunteers Aged 18-40 Years
|
Phase 1 | |
Completed |
NCT04971109 -
Safety, Tolerability and Pharmacokinetics of TPOXX When Administered Orally for 28 Day
|
Phase 3 | |
Completed |
NCT00646152 -
Poly-ICLC to Prevent Respiratory Viral Infections A Safety Study
|
Phase 1 | |
Completed |
NCT01668537 -
A Phase II Trial to Compare a Liquid-frozen and a Freeze-dried Formulation of IMVAMUNE (MVA-BN®) Smallpox Vaccine in Vaccinia-naïve Healthy Subjects
|
Phase 2 |