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

February 18, 2013 updated by: EuBiologics Co.,Ltd

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Chungnam
      • Daejeon, Chungnam, Korea, Republic of, 301-721
        • Chungnam National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Euvichol
Euvichol is a homogeneous suspension of inactivated suitable strains of Vibrio cholera serogroup O1 and O139. Euvichol is Yellow to yellowish colour.
Biological: Euvichol
1.5mL/vial, 1vial at 2-week intervals twice
Other Names:
  • Oral Cholerae Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From the date of the first orally administered for 4 weeks after the second dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity(vibriocidal antibody assay)
Time Frame: Baseline(before the administration), 14 days after first dose, 14 days after second dose
Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline
Baseline(before the administration), 14 days after first dose, 14 days after second dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EuBiologics Co.,Ltd

Collaborators

Instituto Universitario IVI

Investigators

  • Principal Investigator: Hong J Hee, Ph.D, Chungnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 9, 2012

First Submitted That Met QC Criteria

October 14, 2012

First Posted (Estimate)

October 16, 2012

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBC101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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