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Safety and Immunogenicity of a Single Oral Dose of Recombinant Double-Mutant Heat-Labile Toxin (dmLT) Derived from Enterotoxigenic Escherichia coli (ETEC)

This article, published in Clinical and Vaccine Immunology, reports on a Phase 1 clinical trial which determined the safety and immunogenicity of a recombinantly produced dmLT of ETEC. Study results showed that a single oral dose of dmLT was well tolerated and immunogenic, with immune responses plateauing at the 50 μg dose. It is not known how effective the dmLT may be, when given alone or in combination with other ETEC antigens, in preventing wild-type ETEC-induced diarrhea. However, these encouraging results warrant further investigation of the dmLT in future Phase 1 and 2 trials of new ETEC vaccines, or with other enteric vaccine candidates where preclinical studies indicate that the inclusion of dmLT improves immunogenicity and protective efficacy. ABSTRACT ONLY. (Learn how users in developing countries can gain free access to journal articles.)

Author: El-Kamary SS, Cohen MB, Bourgeois AL, et al.

Published: 2013

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(Located at cvi.asm.org)

Citation: El-Kamary SS, Cohen MB, Bourgeois AL, et al. Safety and Immunogenicity of a Single Oral Dose of Recombinant Double-Mutant Heat-Labile Toxin (dmLT) Derived from Enterotoxigenic Escherichia coli (ETEC). Clinical and Vaccine Immunology. 2013; Early Online Publication.

Resource types: Peer-reviewed journal

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

Topics: Disease/vaccine specific information

Regions: Global