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Safety and Immunogenicity of an Improved Oral Inactivated Multivalent Enterotoxigenic Escherichia coli (ETEC) Vaccine Administered Alone and Together with dmLT Adjuvant in a Double-Blind, Randomized, Placebo-Controlled Phase I Study

This article, published in Vaccine, reports on the results of a Phase 1 study of an oral vaccine candidate against enterotoxigenic Escherichia coli (ETEC) administered in combination with a novel mucosal adjuvant, the double-mutant heat-labile toxin (dmLT). The vaccine was found to be safe and well tolerated; adverse events were few and generally mild with no significant differences between subjects receiving placebo or vaccine with or without adjuvant. In addition, the vaccine induced immune responses to all major vaccine antigens, and the dmLT adjuvant enhanced mucosal responses to antigens present in low amounts in the vaccine.

Author: Lundgren A, Bourgeois L, Carlin N, et al.

Published: 2014

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(Located at www.sciencedirect.com)

Citation: Lundgren A, Bourgeois L, Carlin N, et al. Safety and Immunogenicity of an Improved Oral Inactivated Multivalent Enterotoxigenic Escherichia coli (ETEC) Vaccine Administered Alone and Together with dmLT Adjuvant in a Double-Blind, Randomized, Placebo-Controlled Phase I Study. Vaccine. 2014;32(52):7077-7084.

Resource types: Peer-reviewed journal

Diseases/vaccines: Shigellosis and enterotoxigenic Escherichia coli (ETEC)

Topics: Vaccine safety and performance, Disease/vaccine specific information

Regions: North America and Europe