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To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men (OCV)

Primary Purpose

Prevention Harmful Effects

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Euvichol
Sponsored by
EuBiologics Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention Harmful Effects focused on measuring OCV, cholera

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Chungnam National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Euvichol

Arm Description

Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Immunogenicity(vibriocidal antibody assay)
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline

Full Information

First Posted
October 9, 2012
Last Updated
February 18, 2013
Sponsor
EuBiologics Co.,Ltd
Collaborators
Instituto Universitario IVI
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1. Study Identification

Unique Protocol Identification Number
NCT01707537
Brief Title
To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
Acronym
OCV
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuBiologics Co.,Ltd
Collaborators
Instituto Universitario IVI

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention Harmful Effects
Keywords
OCV, cholera

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Euvichol
Arm Type
Experimental
Arm Description
Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour.
Intervention Type
Biological
Intervention Name(s)
Euvichol
Other Intervention Name(s)
Oral Cholerae Vaccine
Intervention Description
1.5mL/vial, 1vial at 2-week intervals twice
Primary Outcome Measure Information:
Title
Safety(proportion of subjects with adverse events)
Description
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
Time Frame
From the date of the first orally administered for 4 weeks after the second dose
Secondary Outcome Measure Information:
Title
Immunogenicity(vibriocidal antibody assay)
Description
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
Time Frame
Baseline(before the administration), 14 days after first dose, 14 days after second dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong J Hee, Ph.D
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Chungnam
ZIP/Postal Code
301-721
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
24753695
Citation
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. Erratum In: J Korean Med Sci. 2014 Aug;29(8):1182.
Results Reference
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To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men

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