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Vaccine. 2007 May 4;25(18):3684-91. Epub 2007 Jan 23.

Transcutaneous immunization with the heat-labile toxin (LT) of enterotoxigenic Escherichia coli (ETEC): protective efficacy in a double-blind, placebo-controlled challenge study.

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



An enterotoxigenic Escherichia coli (ETEC) vaccine could reduce diarrhea among children in developing countries and travelers to these countries. The heat-labile toxin (LT) of ETEC is immunogenic but too toxic for oral or nasal vaccines.


In a double-blind, placebo-controlled trial, 59 adults were randomized to receive 50 microg of LT or placebo in a patch applied to alternating arms on days 0, 21, and 42. On day 56, 27 vaccinees and 20 controls were challenged orally with 6x10(8) cfu of LT+/ST+ ETEC.


100 and 97% of vaccinees had 4-fold increases in anti-LT IgG and IgA, and 100 and 90% developed IgG- and IgA-antibody-secreting cell responses. The study did not meet the primary endpoint: 82% of vaccinees and 75% of controls had moderate to severe ETEC illness. However, vaccinees with ETEC illness had lower numbers (6.8 versus 9.7, p=0.04) and weights of loose stools (840 g versus 1147 g, p<0.05), a decreased need for intravenous fluids (14% versus 40%, p=0.03) and a delayed onset of diarrhea (30 h versus 22 h, p=0.01).


Transcutaneous LT vaccination induced anti-toxin immune responses that did not prevent but mitigated illness following a high-dose challenge with a virulent LT+/ST+ ETEC strain.

[PubMed - indexed for MEDLINE]
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