Prevention Harmful EffectsPhase 1OCVNCT01707537
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
A Phase 1 study testing Euvichol in people with Prevention Harmful Effects, run by EuBiologics Co.,Ltd at 1 site in South Korea.
Trial summary
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention Harmful Effects
- What is being tested?
- Euvichol
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Feb 2013
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult men over 20years of age
- More than 45kg body weight and ideal body weight within ±20% of the weight
- Screening was conducted within 14 days of investigational drug administration (Vital Sign \& Physical Examination, hematology and blood coagulation tests, blood chemistry tests, urinalysis, 12-lead ECG, etc.), the results at the discretion of the investigator deemed suitable for participation in clinical trials
- Written consent person who determines to participate in a clinical trial
Who cannot join
- A person who showed hypersensitivity when other preventive vaccination in the past
- A person who have received cholera vaccine in the past
- A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment
- A person who had gastrointestinal symptoms such as diarrhea, abdominal pain, or have been received prescription drug within one week before the start of the experiment
- A person who was lasted for more than two weeks of symptoms such as diarrhea, abdominal pain within 6months before the start of the experiment
- A person who donate whole blood or component of blood within one months before the start of the experiment if the donors
Show all 13Show fewer
- A person who received other preventive vaccine within 2months before the start of the experiment
- A person who received blood products of immune globulin preparations within 3months before the start of the experiment
- A person who has immune function disorders or are receiving immunosuppressive treatment
- A person who has chronic illness in progress
- Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking)
- A person who participate in clinical trials treated with the investigational drug within 2months before the start of the experiment
- A person who is difficult to participate in this clinical trials as the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, 301-721
About this study
Official title: Phase I Study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative Clinical Trial
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
Read the detailed description
This clinical trial is open, non-comparative phase 1 clinical studies in healthy men and has been designed to determine the safety and immunogenicity of Euvichol(Oral cholera vaccine)
- Conditions
- Prevention Harmful Effects
- Being tested
- Euvichol
- Keywords
- OCV, cholera
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EuvicholBiological
Also called Oral Cholerae Vaccine
1.5mL/vial, 1vial at 2-week intervals twice
| Study group | Role | What they receive |
|---|---|---|
| Euvichol | Experimental | Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour. Receives: Biological: Euvichol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety(proportion of subjects with adverse events)
The proportion of all adverse event and serious adverse event which were occured during the entire study period is analyzed and casuality between severity and investigational product is presented.
Check the vital signs, physical examination and clinical laboratory tests
Measured: From the date of the first orally administered for 4 weeks after the second dose
Secondary outcomes (1)
Immunogenicity(vibriocidal antibody assay)
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
Measured: Baseline(before the administration), 14 days after first dose, 14 days after second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
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 Prevention Harmful EffectsStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario IVI
- Responsible party
- Sponsor
- Investigators
- Hong J Hee, Ph.D, Principal investigator, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01707537
- Sponsor's protocol ID
- UBC101
- Acronym
- OCV
- Status last verified
- Feb 2013
- First submitted
- 9 Oct 2012
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Baik YO, Choi SK, Kim JW, Yang JS, Kim IY, Kim CW, Hong JH. Safety and immunogenicity assessment of an oral cholera vaccine through phase I clinical trial in Korea. J Korean Med Sci. 2014 Apr;29(4):494-501. doi: 10.3346/jkms.2014.29.4.494. Epub 2014 Apr 1.
PubMed 24753695
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT01707537
- Acronym / sponsor ID
- OCV / UBC101
- Conditions
- Prevention Harmful Effects
- Keywords
- OCV, cholera
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Universitario IVI
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Oct 2012 (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.
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
Detailed description
This clinical trial is open, non-comparative phase 1 clinical studies in healthy men and has been designed to determine the safety and immunogenicity of Euvichol(Oral cholera vaccine)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Euvichol | Experimental | Biological: EuvicholEuvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men over 20years of age
- More than 45kg body weight and ideal body weight within ±20% of the weight
- Screening was conducted within 14 days of investigational drug administration (Vital Sign \& Physical Examination, hematology and blood coagulation tests, blood chemistry tests, urinalysis, 12-lead ECG, etc.), the results at the discretion of the investigator deemed suitable for participation in clinical trials
- Written consent person who determines to participate in a clinical trial
Key exclusion criteria (13 listed)
- A person who showed hypersensitivity when other preventive vaccination in the past
- A person who have received cholera vaccine in the past
- A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment
- A person who had gastrointestinal symptoms such as diarrhea, abdominal pain, or have been received prescription drug within one week before the start of the experiment
- A person who was lasted for more than two weeks of symptoms such as diarrhea, abdominal pain within 6months before the start of the experiment
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 |
|---|---|---|
| EuvicholAlso: Oral Cholerae Vaccine1.5mL/vial, 1vial at 2-week intervals twice | Biological | Euvichol |
Primary outcome
Safety(proportion of subjects with adverse events)
Time frame: From the date of the first orally administered for 4 weeks after the second dose
The proportion of all adverse event and serious adverse event which were occured during the entire study period is analyzed and casuality between severity and investigational product is presented. Check the vital signs, physical examination and clinical laboratory tests
1 secondary outcome
Immunogenicity(vibriocidal antibody assay)
Time frame: Baseline(before the administration), 14 days after first dose, 14 days after second dose
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 20 Feb 2013.
- Derived from this study: PubMed 24753695Baik YO, Choi SK, Kim JW, Yang JS, Kim IY, Kim CW, Hong JH. Safety and immunogenicity assessment of an oral cholera vaccine through phase I clinical trial in Korea. J Korean Med Sci. 2014 Apr;29(4):494-501. doi: 10.3346/jkms.2014.29.4.494. Epub 2014 Apr 1.
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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.
Hong J Hee, Ph.D principal investigator
Chungnam 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 Euvichol in people with Prevention Harmful Effects, run by EuBiologics Co.,Ltd 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 4 inclusion and 13 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 20 Feb 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 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(proportion of subjects with adverse events) (time frame: From the date of the first orally administered for 4 weeks after the second dose). 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 NCT01707537, 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 20 Feb 2013.