Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Primary objectives: 1-To assess safety of 10E8-10E9 CFU single dose of 638 V. chorelae O1 El Tor Ogawa, a lyophilized live attenuated vaccine. 2-To assess reactogenicity during 14 days after application of vaccine or placebo. 3-To assess the vibriocidal antibody response against Ogawa serotype on days 0, 14 and 21 after treatment. Primary endpoints: 1-Incidence and relationship to the vaccine and (or) placebo administration of any serious adverse event within 30 days after vaccination. 2-Incidence of any grade 3 adverse event within 14 days after vaccine and (or) placebo administration. 3-Incidence of any other expected adverse events taking place within 14 days after treatment. 4-Incidence, intensity and relationship to the vaccine and (or) placebo administration of unexpected adverse events within 30 days after vaccination. 5-Incidence of out of normality range values and with clinical significance of the clinical lab tests, 7 days after vaccine and (or) placebo administration. 6-The Geometrical Mean titers of vibriocidal antibodies before vaccination, and on days 14, and 21 after vaccination in both groups of study. 7-Seroconversion defined as a fourfold increase of the initial titer with respect to the days 14 and (or) 21 titers in both groups of study.
Key secondary outcomes:
Secondary objectives: 1-To identify and to quantify, the attenuated 638 strains V. cholerae O1 El Tor Ogawa, excreted by volunteers every each third day, during the next 30 days after immunization. 2-To assess the ribotype, the lack of ctxAB genes, the presence of the hap::celA allele and the expression of CelA and OmpU proteins in V. cholerae O1 biotype El Tor strains isolated from volunteers stools on days 3, 6, 9, 15 and 30 of the study. 3-To describe the quantitative variation of CD4 and CD8 lymphocytes subpopulations and HIV viremia in volunteers, after treatment. Secondary endpoints: 1-To describe by mean of a survival analysis the dynamic of excretion, defining the event of interest as the occurrence of the third consecutive stool cultures negative of the attenuated 638 V. cholerae O1 El Tor Ogawa strain. 2-To calculate percentage of volunteers who shed the attenuated 638 strain V. cholerae O1 El Tor Ogawa every each 3 days during the next 30 days after vaccine feeding or until the occurrence of 3 consecutive stool negative cultures for 638 strain in both groups of study. 3-Percentage of V. cholerae O1 El Tor strains isolated from stools of volunteers on days 3, 6, 9, 15 and 30, which match with the 638 vaccine strain in the ribotype, the lack of ctxAB genes, the presence of the hap::celA allele, the expression of CelA and the lack of the expression of the OmpU proteins. 4-The mean, range and standard deviation to describe the variation of CD4 and CD8 lymphocytes subpopulations and HIV viremia in positive HIV volunteers on days 7, 14 and 21 after vaccination, as well as to describe the variation of CD4 and CD8 lymphocytes subpopulations using non-parametric test.
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