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

Robin McKenzie, Michael Darsley, Nicola Thomas, Roger Randall, Colleen Carpenter, Edrick Forbes, Mariel Finucane, R. Bradley Sack, Eric Hall, August L. Bourgeois

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)4731-4739
Number of pages9
JournalVaccine
Volume26
Issue number36
DOIs
StatePublished - Aug 26 2008

Keywords

  • Diarrhea
  • ETEC
  • Enterotoxigenic E. coli
  • Live attenuated vaccine
  • Oral vaccine

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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