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Completed

NCT Number: NCT01707537

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

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

Completed

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Key information

Conditions

Prevention Harmful Effects Bacterial Infections Bacterial Infections and Mycoses Cholera Gram-Negative Bacterial Infections Infections Vibrio Infections

Age range

20 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, 301-721, South Korea

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Euvichol

Biological

1.5mL/vial, 1vial at 2-week intervals twice

Other names: Oral Cholerae Vaccine

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

EuBiologics Co.,Ltd

Industry

Collaborators

  • Instituto Universitario IVI

Registry information

Official study 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

Acronym: OCV

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2012
Registry last updated
Feb 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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