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

Phase I study to Determine the Safety and Immunogenicity of Euvichol(Oral Cholera Prevention Vaccine)in Healthy Adult Men ; Open, Non-comparative clinical trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0000540

Enrollment

Registered

2012-09-20

Start date

2012-09-24

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine : Euvichol(Oral cholera vaccine), 1vial(1.5mL), Administered orally twice at 2-week intervals(Total 2vials)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1) Adult men over 20years of age 2) More than 45kg body weight and ideal body weight within ±20% of the weight 3)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 4) Written consent person who determines to participate in a clinical trial

Exclusion criteria

Exclusion criteria: 1) A person who showed hypersensitivity when other preventive vaccination in the past 2) A person who have received cholera vaccine in the past 3) A person who had a febrile illness or infection disease, or have received antibiotics within 2weeks before the start of the experiment 4) 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 5) 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 6) A person who donate whole blood or component of blood within one months before the start of the experiment if the donors 7) A person who received other preventive vaccine within 2months before the start of the experiment 8) A person who received blood products of immune globulin preparatios within 3months before the start of the experiment 9) A person who has immune function disorders or are receiving immunosuppressive treatment 10) A person who has chronic illness in progress 11) Ongoing drug and alcohol abuse(Not more than 28 units/week for drinking) 12) A person who participate in clinical trials treated with the investigational drug within 2months before the start of the experiment 13) A person who is difficult to participate in this clinical trials as the discretion of the investigator

Design outcomes

Primary

Measure	Time frame
safety, Tolerability	—

Secondary

Measure	Time frame
Immunogenicity(Evaluation of antibody seroconversion)	—

Countries

Korea, Republic of

Contacts

Public ContactJung Kyung

Chungnam National University Hospital

Outcome results