SmallpoxPhase 1NCT00336635
Safety and Immunogenicity of CJ-50300
A Phase 1 study testing cell-culture derived smallpox vaccine in people with Smallpox, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 is urgently needed because previous manufacturing methods using calf lymph are no longer acceptable in the view of current standards. Read more about this study
- Who is it for?
- Ages 20 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- cell-culture derived smallpox vaccine
- Type of treatment
- Vaccines
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Feb 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Korean male and female subjects between 20 and 28 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
Who cannot join
- 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 with inflammatory ophthalmic disease requiring steroid therapy
Show all 21Show fewer
- 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 invesigator's judgement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I
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 is 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 phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.
- Conditions
- Smallpox
- Being tested
- cell-culture derived smallpox vaccine
- Keywords
- smallpox, vaccine, immunity
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cell-culture derived smallpox vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and immunogenicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2006 (estimated)
- Study startJun 2006
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmallpoxStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation
- Investigators
- Myoung-don Oh, MD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336635
- Sponsor's protocol ID
- CJ_SPX_101
- Status last verified
- Apr 2007
- First submitted
- 13 Jun 2006
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SH, Choi SJ, Park WB, Kim HB, Kim NJ, Oh MD, Choe KW. Detailed kinetics of immune responses to a new cell culture-derived smallpox vaccine in vaccinia-naive adults. Vaccine. 2007 Aug 14;25(33):6287-91. doi: 10.1016/j.vaccine.2007.05.044. Epub 2007 Jun 11.
PubMed 17597266
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Control Study to Evaluate the Safety and Immunogenicity of CJ-50300 in Healthy Volunteers : Phase I
- ClinicalTrials.gov ID
- NCT00336635
- Acronym / sponsor ID
- CJ_SPX_101
- Conditions
- Smallpox
- Keywords
- smallpox, vaccine, immunity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- HK inno.N Corporation
- Study start
- Jun 2006
- Study completion
- Feb 2007 (actual)
- First posted
- 14 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 is 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 phase 1 clinical trial were to assess safety, reactogenicity, and immunogenicity of CJ-50300.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy Korean male and female subjects between 20 and 28 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cell-culture derived smallpox vaccine | Biological | – |
Primary outcome
safety and immunogenicity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
- Derived from this study: PubMed 17597266Kim SH, Choi SJ, Park WB, Kim HB, Kim NJ, Oh MD, Choe KW. Detailed kinetics of immune responses to a new cell culture-derived smallpox vaccine in vaccinia-naive adults. Vaccine. 2007 Aug 14;25(33):6287-91. doi: 10.1016/j.vaccine.2007.05.044. Epub 2007 Jun 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myoung-don Oh, MD study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cell-culture derived smallpox vaccine in people with Smallpox, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and immunogenicity. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00336635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.