Live attenuated enterotoxigenic Escherichia coli (ETEC) vaccine with dmLT adjuvant protects human volunteers against virulent experimental ETEC challenge.

In the ACE527 + dmLT group, there were also highly significant reductions in the incidence of diarrhea of any severity (VE = 58.5%, p = 0.016 2-sided FET) and in the median total weight and total number of stools passed.

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Among the 36 randomized volunteers from Part A that went on to be challenged with H10407 in Part B, there was a strong trend toward those having modest anti-CFA/I ALS responses (≥3 fold over baseline) at some point post-immunization having a reduced risk of developing severe diarrhea post-challenge (PE = 43.8%; p = 0.09 by Fishers Exact Test) (data not shown).

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