Phase I-II study of live oral cholera vaccine 638 in healthy adult volunteers in Cuba.

Phase 1

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

• Registration Number: RPCEC00000053
• Lead Sponsor: Finlay Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified