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.

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.

journal_name

Vaccine

journal_title

Vaccine

authors

McKenzie R,Darsley M,Thomas N,Randall R,Carpenter C,Forbes E,Finucane M,Sack RB,Hall E,Bourgeois AL

doi

10.1016/j.vaccine.2008.06.064

subject

Has Abstract

pub_date

2008-08-26 00:00:00

pages

4731-9

issue

36

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(08)00796-2

journal_volume

26

pub_type

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