Limitations
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We did not measure antibody responses in stools or cultures of intestine-derived B cells. While these responses may more directly reflect the intestinal SIgA responses, the workload entailed by such large cohort would have been overwhelming and, indeed, the decision appeared justified, since our previous studies have already shown ETVAX® to elicit robust anti-LTB and anti-LPS IgA responses both in faeces and cultures of intestine-derived peripheral blood B cells.The bicarbonate buffer used in vaccine/placebo may account for part of the symptoms in both groups and also explain some of the high AE rates in the placebo group. Indeed, our analysis comparing the two groups aimed at revealing reactions to the vaccine component in the active preparation.Proportion of participants with ≥2-fold (≥4-fold) increase in LTB- and O78 LPS-specific IgA and IgG levels over study period spanning between pre-immunization and post-immunization in vaccine and placebo groups
