TY - JOUR
T1 - 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
AU - McKenzie, Robin
AU - Darsley, Michael
AU - Thomas, Nicola
AU - Randall, Roger
AU - Carpenter, Colleen
AU - Forbes, Edrick
AU - Finucane, Mariel
AU - Sack, R. Bradley
AU - Hall, Eric
AU - Bourgeois, August L.
N1 - Funding Information:
This work was supported by Acambis Research Ltd., Cambridge, UK and by Johns Hopkins University School of Medicine General Clinical Research Center grant number M01-RR00052 from the National Center for Research Resources, NIH.
PY - 2008/8/26
Y1 - 2008/8/26
N2 - 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.
AB - 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.
KW - Diarrhea
KW - ETEC
KW - Enterotoxigenic E. coli
KW - Live attenuated vaccine
KW - Oral vaccine
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U2 - 10.1016/j.vaccine.2008.06.064
DO - 10.1016/j.vaccine.2008.06.064
M3 - Article
C2 - 18602960
AN - SCOPUS:48649103259
SN - 0264-410X
VL - 26
SP - 4731
EP - 4739
JO - Vaccine
JF - Vaccine
IS - 36
ER -