Cholera disease
Conditions
Interventions
The vaccine under study, formulated at the Finlay Institute, is a lyophilized live oral vaccine, composed by the attenuated strain 638 V. cholerae from the serogroup O1, the biotype El Tor and the ser
stage 1 evaluated two antiacid as the vaccine dissolvents. In this stage participated 16 volunteers whom were feeding with the vaccine, 8 volunteers with the vaccine diluted into the antiacid A (1,33%
4 with the antiacid A and 4 with the antacid B. The stage 2 was conformed by 18 volunteers whom were fed with the vaccine dissolved into the antiacid B and 6 volunteers from the placebo group whom wer
Administration, Oral
Placebos
Sponsors
Finlay Institute
Cuban National Center for Scientific Research
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objectives: 1-To assess safety of 1-9x10E9 CFU of a single dose of 638 V. chorelae O1 El Tor Ogawa, a lyophilized live attenuated oral cholera vaccine. 2-To assess reactogenicity during 5 days after application of vaccine or placebo. 3-To assess the vibriocidal antibody response against Ogawa serotype on days 14, 28, 42, at month 6 and one year after. Primary endpoints: Safety and Reactogenicity: 1-Incidence of any expected grade 3 adverse event within 5 days after vaccine and (or) placebo administration. 2-Incidence of any other expected adverse events taking place within 7 days after treatment. 3-Incidence, intensity and relationship to the vaccine and (or) placebo administration of any unexpected adverse even during the whole trial (30 days). 4-Incidence and relationship to the vaccine and (or) placebo administration of any serious adverse events during the whole trial (30 days). 5-Incidence of clinical lab tests with pathologic values 7 days after vaccine and (or) placebo administration. 6-Identification of attenuated 638 strain V. cholerae O1 El Tor Ogawa, excreted by volunteers 5 days before and 3 days after the antibiotic treatment. Immunogenicity: 1-The Geometrical Mean Titer (GMT) of vibriocidal antibodies: Estimation of the mean of vibriocidal antibody titers detected in serum samples on days 14, 28, 42, at month 6 and one year after treatment in comparison with the titers before vaccine and (or) placebo administration. 2-Assessment of seroconversion: Seroconversion defined as a fourfold increase of vibriocidal antibody titers on days 14, 28, 42, at month 6 and one year after treatment in comparison with the titers before vaccine and (or) placebo administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objective: To demonstrate vaccine plus antiacid proposed as a final formulation, is suitable as the vaccine mixed with 1.33% sodium bicarbonate. Secondary endpoints: 1-Incidence, intensity and relation to the placebo plus antiacid A administration of any unexpected adverse event during the first stage (30 days). 2-Incidence, intensity and relation to the placebo plus B antiacid administration of any unexpected adverse event during the first stage (30 days). 3-Statistic signification (“p value”) between immunogenicity results of volunteers who were fed with placebo mixed with antiacid A and immunogenicity results of volunteers fed with placebo mixed with antiacid B. | — |
Countries
Cuba
Contacts
Public ContactHilda Garcia Sanchez
Finlay Institute
Outcome results
None listed