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.

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.

RCT Entities:   Population Interventions Outcomes