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Vaccine. 2008 Aug 26;26(36):4731-9. doi: 10.1016/j.vaccine.2008.06.064. Epub 2008 Jul 9.

A double-blind, placebo-controlled trial to evaluate the efficacy of PTL-003, an attenuated enterotoxigenic E. coli (ETEC) vaccine strain, in protecting against challenge with virulent ETEC.

Author information

  • 1Division of Infectious Diseases, Johns Hopkins University, Johns Hopkins Bayview Medical Center, 4940 Eastern Avenue, Baltimore, MD 21224, United States. rmckenz@jhmi.edu

Abstract

Enterotoxigenic E. coli (ETEC) are an important cause of diarrhea in developing countries, especially among indigenous children and travelers. In this randomized, double-blind, placebo-controlled trial, a live, attenuated CS1/CS3 ETEC strain, PTL-003, was tested as a potential vaccine strain. Thirty-three subjects drank buffered solutions containing either PTL-003 or placebo on Days 0 and 10 and were challenged with virulent CS1/CS3 ETEC strain E24377A on Day 28. The vaccine did not protect against moderate to severe ETEC illness (the primary endpoint), but it did prime subjects for a rapid antibody response to CS1 and CS3 after challenge, suggesting that a dose of vaccine on Day 28 might improve the immune response to the vaccine. Higher serum anti-CS3 IgA titers at the time of challenge correlated with less severe diarrheal illness.

PMID:
18602960
[PubMed - indexed for MEDLINE]
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