Challenge study to determine the protective efficacy of a single oral dose of the attenuated 638 strain.

Not Applicable

• Conditions: Cholera disease; Healthy Volunteers; Cholera /prevention & control; Vibrio Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Waterborne Diseases; Environmental Illness

• Registration Number: RPCEC00000072
• Lead Sponsor: Finlay Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

1-Healthy man between 18 to 40 years of age. 2-Free from obvious health problems as established by medical history, clinical examination, laboratory tests and psychometric tests before entering into the study. 3-Written informed consent obtained from the subjects.

Exclusion Criteria

1-Previous history of immunodeficiency. 2-Cardiovascular, respiratory, renal, hematological, hepatic, gastrointestinal, neurological, endocrine, and psychiatric diseases or reticuloendothelial system disorders detected during the clinical examination or by laboratory tests. 3-Allergy to tetracyclines. 4-Previous cholera vaccination or challenge with V. cholera virulent strain (applicable only to the stage I). 5-Administration of immunoglobulins and/or antibiotics within 30 days preceding the treatment. 6-Positive serological test for human HIV-1-2 virus antibodies. 7-Positive serological test for human hepatitis B surface antigen, or hepatitis A and C antibodies. 8-Stool cultures positive for an enteric pathogen. 9-Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the treatment. Inhaled and topical steroids are allowed. 10-Administration of a vaccine not foreseen by the study protocol during the period starting one month before the application of the study vaccine and ending one month after that application. 11-Anu acute disease, moderate or severe, at the time of enrollment. 12-Do not approve a written examination about cholera.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Objective: To assess the protective efficacy of the attenuated 638 strain in volunteers, by mean of a challenge study with a homologous biotype and serotype cholera virulent strain. Primary endpoints: 1-Incidence of diarrheas in both groups during the 5 days after virulent strain feeding