Clinical trial NCT01707537: To Determine the Safety and Immunogenicity of an Oral(Whole Cell) Euvichol Cholera Vaccine in Healthy Adult Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prevention Harmful Effects
Keywords: OCV
cholera
Lead sponsor: EuBiologics Co.,Ltd
Sponsor class: INDUSTRY
Collaborators: name: Instituto Universitario IVI
First posted: 2012-10-16
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Safety(proportion of subjects with adverse events)
timeFrame: From the date of the first orally administered for 4 weeks after the second dose
Secondary outcomes:
measure: Immunogenicity(vibriocidal antibody assay)
timeFrame: Baseline(before the administration), 14 days after first dose, 14 days after second dose
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Chungnam
Study officials:
affiliation: Chungnam National University Hospital
name: Hong J Hee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.