Cholera disease
Conditions
Interventions
The volunteers were randomly distributed in two parallel groups respectively, vaccine or placebo. In the vaccine group 15 volunteers were fed with a single oral dose of 10E9 CFU of a freshly harvested
Administration, Oral
Placebos
Sponsors
Finlay Institute
Centro Nacional de Investigaciones Científicas (CNIC) (Cuban National Center for Scientific Researches)
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: 1-To assess the safety and reactogenicity of the attenuated 638 strain in volunteers during 5 days after immunization. 2-To assess mucosal and systemic immunogenicity of the attenuated 638 strain in volunteers during the trial. 3-To assess the immune response induced by the virulent strain in those volunteers whom were previously fed in the stage I, with the placebo and the attenuated 638 strain. 4-To identify and to quantify the attenuated and virulent strains excreted by volunteers 5 days before and 3 days after the antibiotic treatment. 5-To assess the dynamic of the immune response against Vibrio cholerae until 28 days after inoculation in both stages of the study. Secondary endpoints: Safety and Reactogenicity: 1-Incidence of expected adverse event grade 3 within 5 days after the attenuated 638 strain feeding. 2-Incidence of grade 3 diarrheas during the following 5 days after application of the attenuated 638 strain (Stage 1). 3-Incidence of diarrheas of any intensity during the following 5 days after application of the attenuated 638 strain (Stage 1). 4-Incidence of any other expected adverse events of intensity grade 3, in the same period of time. 5-Incidence of any other expected adverse events of whatever intensity, observed in the same period of time. 6-Incidence, intensity and relationship to the attenuated 638 strain administration of whatever unexpected adverse event during the whole trial. 7-Incidence, intensity and relationship to the attenuated 638 strain administration of any serious adverse event during the whole trial. 8-Incidence of clinical lab tests with pathologic values, 7 days after the attenuated 638 strain feeding. Immunogenicity: 1-Seroconversion of vibriocidal antibodies expressed as the increase of titer in sera in four or more time on day 14 in comparison with the preimmune titer. 2-Seroconversion of ELISA anti-Ogawa LPS IgA, IgM and IgG antibodies in sera expressed as the increase of titer in sera in two or more | — |
Countries
Cuba
Contacts
Public ContactHilda Garcia Sanchez
Finlay Institute. Center for Research and Production of Vaccines
Outcome results
None listed