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

NCT01707537 | Completed Phase 1 DMC

• 1 other identifier: UBC101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prevention Harmful Effects

Keywords

OCV; cholera

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Immunogenicity(vibriocidal antibody assay)

  Baseline(before the administration), 14 days after first dose, 14 days after second dose

Study Arms (1)

Euvichol

EXPERIMENTAL

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

Biological: Euvichol

Interventions

Euvichol BIOLOGICAL

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

Also known as: Oral Cholerae Vaccine

Euvichol

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EuBiologics Co.,Ltd: lead
• Instituto Universitario IVI: collaborator

Study Sites (1)

Chungnam National University Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 24753695 DERIVED

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Hong J Hee, Ph.D

  Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2012
• First Posted: October 16, 2012
• Study Start: September 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 20, 2013

Record last verified: 2013-02

Locations

KR (1)