Clinical Trial to Evaluate Safety and Immunogenicity of an Oral Inactivated Enterotoxigenic Escherichia coli Prototype Vaccine Containing CFA/I Overexpressing Bacteria and Recombinantly Produced LTB/CTB Hybrid Protein
This article, published in Vaccine, describes the results of a randomized, comparator controlled, double-blind Phase 1 trial in 60 Swedish adults testing a prototype of a new oral vaccine candidate against enterotoxigenic Escherichia coli (ETEC) diarrhea. The vaccine contained killed recombinant E. coli bacteria expressing increased levels of ETEC colonization factors (CFs) and a recombinant protein (LCTBA), i.e., a hybrid between the binding subunits of E. coli heat labile toxin (LTB) and cholera toxin (CTB). The results described in the article demonstrate that CF over-expression and inclusion of the LCTBA hybrid protein in an oral inactivated ETEC vaccine does not change the safety profile when compared to a previous generation of such a vaccine and that the prototype vaccine induces significant dose-dependent mucosal immune responses against CFA/I and LTB. ABSTRACT ONLY. (Learn how users in developing countries can gain free access to journal articles.)
Author: Lundgren A, Leach S, Tobias J, et al.
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Citation: Lundgren A, Leach S, Tobias J, et al. Clinical Trial to Evaluate Safety and Immunogenicity of an Oral Inactivated Enterotoxigenic Escherichia coli Prototype Vaccine Containing CFA/I Overexpressing Bacteria and Recombinantly Produced LTB/CTB Hybrid Protein. Vaccine. 2013;31(8):1163-1170.
Resource types: Peer-reviewed journal
Diseases/vaccines: Shigellosis and enterotoxigenic Escherichia coli (ETEC)
Regions: North America and Europe