Double-Blind, Randomized, Placebo Controlled Pilot Study Evaluating Efficacy and Reactogenicity of an Oral ETEC B-Subunit-Inactivated Whole Cell Vaccine against Travelers’ Diarrhea (Preliminary Report)

Abstract

Diarrhea caused by enterotoxigenic E.coli (ETEC) is an important health problem in developing countries and in travelers to these areas. In previous trials formulations of ETEC vaccines containing the B-subunit of cholera toxin, which is antigenically similar to the heat labile enterotoxin of ETEC, and the most prevalent colonization factor antigens of ETEC, were shown to stimulate relevant mucosal immune responses in volunteers from Sweden and Egypt.