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

Prevention Harmful Effects Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707537
• Other study ID #: UBC101
• Status: Completed
• Phase: Phase 1
• First received: October 9, 2012
• Last updated: February 18, 2013
• Start date: September 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: EuBiologics Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholera
• Prevention Harmful Effects

Intervention

Biological:
• Euvichol
1.5mL/vial, 1vial at 2-week intervals twice

Locations

Country	Name	City	State
Korea, Republic of	Chungnam National University Hospital	Daejeon	Chungnam

Sponsors (2)

Lead Sponsor	Collaborator
EuBiologics Co.,Ltd	Instituto Universitario IVI

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From the date of the first orally administered for 4 weeks after the second dose	Yes
Secondary	Immunogenicity(vibriocidal antibody assay)	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	No