SmallpoxPhase 2/3NCT00607243
Safety and Efficacy of CJ-50300 in Healthy Volunteers
A Phase 2/3 study testing smallpox vaccine CJ-50300 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 are 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 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Smallpox
- What is being tested?
- smallpox vaccine CJ-50300
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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 requiring steroid therapy
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, a Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CJ-50300 in Healthy Volunteers
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.
- Conditions
- Smallpox
- Being tested
- smallpox vaccine CJ-50300
- Keywords
- Smallpox vaccine efficacy
- Medical subject headings
- Smallpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smallpox vaccine CJ-50300Biological
Also called CJ-53300
Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose
| Study group | Role | What they receive |
|---|---|---|
| Conventional dose group | Experimental | Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination Receives: Biological: smallpox vaccine CJ-50300 |
| Low dose group | Experimental | Diluted CJ-50300 2.5 x 10000pfu/dose vaccination Receives: Biological: smallpox vaccine CJ-50300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cutaneous Take Reaction
The "take reaction"was 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.
Measured: 7-9 day
Adverse Reactions
Measured: 0-28 days
Secondary outcomes (2)
Antibody Response
Measured: 14 or 28 days
Cell-mediate Immunity
Measured: 14 or 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HK inno.N Corporation
- Responsible party
- Principal investigator, Myoung-don Oh, Seoul National University Hospital
- Investigators
- Myoung-don Oh, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00607243
- Sponsor's protocol ID
- CJ_SPX_301
- Other IDs
- CJ corporation
- Status last verified
- Jul 2013
- First submitted
- 31 Jan 2008
- Last updated
- 9 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jang HC, Kim CJ, Kim KH, Lee KH, Byun YH, Seong BL, Saletti G, Czerkinsky C, Park WB, Park SW, Kim HB, Kim NJ, Oh MD. A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers. Vaccine. 2010 Aug 16;28(36):5845-9. doi: 10.1016/j.vaccine.2010.06.063. Epub 2010 Jun 30.
PubMed 20600480
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, a Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CJ-50300 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00607243
- Acronym / sponsor ID
- CJ_SPX_301
- Conditions
- Smallpox
- Keywords
- Smallpox vaccine efficacy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- HK inno.N Corporation
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Feb 2008 (estimated)
- Results
- Posted 9 Jul 2013
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional dose group | Experimental | Biological: smallpox vaccine CJ-50300Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination |
| Low dose group | Experimental | Biological: smallpox vaccine CJ-50300Diluted CJ-50300 2.5 x 10000pfu/dose vaccination |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 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 |
|---|---|---|
| smallpox vaccine CJ-50300Also: CJ-53300Conventional dose group: 2.5 x 10 5 pfu/dose Diluted dose group:2.5 x 10 4 pfu/dose | Biological | Conventional dose group, Low dose group |
Primary outcome
Cutaneous Take Reaction
Time frame: 7-9 day
The "take reaction"was 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
Time frame: 0-28 days
2 secondary outcomes
Antibody Response
Time frame: 14 or 28 days
Cell-mediate Immunity
Time frame: 14 or 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20600480Jang HC, Kim CJ, Kim KH, Lee KH, Byun YH, Seong BL, Saletti G, Czerkinsky C, Park WB, Park SW, Kim HB, Kim NJ, Oh MD. A randomized, double-blind, controlled clinical trial to evaluate the efficacy and safety of CJ-50300, a newly developed cell culture-derived smallpox vaccine, in healthy volunteers. Vaccine. 2010 Aug 16;28(36):5845-9. doi: 10.1016/j.vaccine.2010.06.063. Epub 2010 Jun 30.
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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, M.D. principal investigator
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 2/3 study testing smallpox vaccine CJ-50300 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 7 inclusion and 22 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 9 Jul 2013. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cutaneous Take Reaction (time frame: 7-9 day). The study lists 2 primary outcomes in all. 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 NCT00607243, 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 9 Jul 2013.