Phase Ib-IIb trial of the live oral cholera vaccine 638 in adult volunteers in Mozambique.

Phase 1

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

• Registration Number: RPCEC00000051
• 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: All
• Target Recruitment: 120

Inclusion Criteria

1-Presumed-healthy adult male and female volunteers, between 18 to 40 years of age. 2-Written informed consent obtained from the subjects.

Exclusion Criteria

1-Clinical manifestation of immunodeficiency. 2-Acute or chronic diseases adverted by volunteer during clinical examination or detected by mean of laboratory test, including bronchial asthma, cancer, neurological diseases, cardiovascular diseases and convulsions. 3-Previous history of immunization with cholera vaccines. 4-Previous cholera infections adverted by volunteers on the last 3 years. 5-History of acute diarrheas 30 days before the beginning of the trial, or chronic diarrheas. 6-Stool positive cultures for V. cholerae. 7-Optical density two times higher than the mean of optical densities of the 3 negative serum in each ELISA assay for IgG cholera antitoxin serum antibodies, in a 1:200 serum dilution, (O.D. serum sample 1:200 > 2 x mean of negatives controls). Otherwise the presence of vibriocidal antibodies titer = 1280 seven days before immunization. 8-Axilary temperature >= 37.5 °C at the very moment of vaccine/placebo administration. 9-Administration of antibiotics, antimalaric drugs, immunoglobulins or any blood products within 30 days preceding the treatment. 10-Subject under antiretroviral treatment. 11-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. 12-Administration of a vaccine not foreseen by the study protocol 30 days before the treatment. 13-Do not approve a written examination in order to ensure the volunteers understanding related to the study and others elemental knowledge about cholera. 14-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. 15-Pregnancy woman or breast-feeding. 16-Alcoholism.

Study & Design

• Study Type: Interventional
• Study Design: Not specified