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

This study has been completed.
Sponsor:
Collaborator:
Instituto Universitario IVI
Information provided by (Responsible Party):
EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01707537
First received: October 9, 2012
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Prevention Harmful Effects
Biological: Euvichol
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by EuBiologics Co.,Ltd:

Primary Outcome Measures:
  • Safety(proportion of subjects with adverse events) [ Time Frame: From the date of the first orally administered for 4 weeks after the second dose ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: Baseline(before the administration), 14 days after first dose, 14 days after second dose ] [ Designated as safety issue: No ]
    Proportion of subjects exhibiting 4-fold or greater rises in titers of serum vibriocidal antibodies, relative to baseline


Enrollment: 20
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Oral Cholerae Vaccine

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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707537

Locations
Korea, Republic of
Chungnam National University Hospital
Daejeon, Chungnam, Korea, Republic of, 301-721
Sponsors and Collaborators
EuBiologics Co.,Ltd
Instituto Universitario IVI
Investigators
Principal Investigator: Hong J Hee, Ph.D Chungnam National University Hospital
  More Information

No publications provided by EuBiologics Co.,Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: EuBiologics Co.,Ltd
ClinicalTrials.gov Identifier: NCT01707537     History of Changes
Other Study ID Numbers: UBC101
Study First Received: October 9, 2012
Last Updated: February 18, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by EuBiologics Co.,Ltd:
OCV
cholera

Additional relevant MeSH terms:
Cholera
Vibrio Infections
Gram-Negative Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 29, 2014