Randomized, double-blind, controlled, phase I-II study to determine the safety, reactogenicity and immunogenicity of a single dose of 1-9 x 10E9 CFU of the live attenuated oral cholera lyophilized vaccine obtained from 638 Vibrio cholerae O1 El Tor Ogawa strain, administered by oral route in healthy adult volunteers from both sex.

Finlay Institute0 sites48 target enrollmentSeptember 19, 2008

ConditionsCholera disease Cholera/ prevention & control Healthy Volunteers Vibrio Infections Gram-Negative Bacterial Infections Bacterial Infections Waterborne Diseases Environmental Illness

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cholera disease
Sponsor: Finlay Institute
Enrollment: 48
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 19, 2008

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Finlay Institute

Eligibility Criteria

Inclusion Criteria

•1\-Healthy female or male aged 18 to 40 years 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. 4\-To approve a written examination in order to ensure the volunteers understanding related to the study (trial) and others elemental knowledge about cholera.

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\-History of Allergy to tetracyclines. 4\-Previous history of immunization with cholera vaccine or infection with cholera. 5\-Administration of immunoglobulins and/or antibiotics within 30 days preceding the treatment. 6\-Positive serological test for human HIV\-1\-2 virus antibody. 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\-Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. 12\-Do not approve a written examination in order to ensure the volunteers understanding related to the study (trial) and others elemental knowledge about cholera. 13\-Pregnancy adverted by women or detected by mean of a rapid B\-HCG pregnancy test on urine. Women during the proximity of the menstrual period at the very moment of the admission of the trial were discarded.