A phase 2, randomised, placebo-controlled study to evaluate once-daily oral Travelan for the prevention of Travellers’ diarrhoea
Abstract
This study evaluated once-daily oral dosing of Travelan (IMM-124E), a bovine polyclonal antibody product, for prevention of Enterotoxigenic Escherichia coli (ETEC)-induced diarrhoea. In this randomised, double-blind, placebo-controlled trial using an ETEC-controlled human infection model, 60 healthy subjects received 1200mg Travelan or placebo once-daily for 7 days. Two days after dosing commenced, subjects were challenged with ETEC strain H10407 and monitored for diarrhoeal symptoms. Travelan was well-tolerated with a significant 50% reduction in ETEC challenge-related adverse events ( P = 0.0001). Efficacy outcomes did not reach statistical significance, largely due to a lower-than-expected placebo attack rate (33% vs 70% anticipated); however a strong trend consistently favoured Travelan, including a 40% reduction in moderate-to-severe diarrhoea (primary endpoint), a 50% reduction in severe diarrhoea, a 44% reduction in all diarrhoea, and a 71% reduction in early antibiotic use. These findings were supported by significant reductions in intestinal inflammation markers (faecal myeloperoxidase and calprotectin) 4 days post-challenge. Significantly lower O78 lipopolysaccharide IgA and IgG titers were observed but over 80% of subjects in each group seroconverted by day 15–29, indicating Travelan did not hinder immunity to ETEC. Although underpowered and limiting definitive interpretation, these findings suggest a potential protective effect of once-daily Travelan, warranting further investigation in a larger adequately powered trial.
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BibTeX
@article{casey2026phase,
title = {{A phase 2, randomised, placebo-controlled study to evaluate once-daily oral Travelan for the prevention of Travellers’ diarrhoea}},
author = {Joanne L. Casey and Frédéric Poly and Chad K. Porter and Kaelyn Lamberti and Charmagne Beckett and Dilara Islam and Renee M. Laird and Sandra D. Isidean and Kayla Testa and Vicky Chapman and Anya Shindler and Ashley E. Franks and Sharon M. Tennant and Wilbur H. Chen and Mohamed Al-Ibrahim and Jerry Kanellos},
journal = {Scientific Reports},
year = {2026},
month = oct,
doi = {10.1038/s41598-026-70974-9},
url = {https://www.nature.com/articles/s41598-026-70974-9},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - A phase 2, randomised, placebo-controlled study to evaluate once-daily oral Travelan for the prevention of Travellers’ diarrhoea
AU - Joanne L. Casey
AU - Frédéric Poly
AU - Chad K. Porter
AU - Kaelyn Lamberti
AU - Charmagne Beckett
AU - Dilara Islam
AU - Renee M. Laird
AU - Sandra D. Isidean
AU - Kayla Testa
AU - Vicky Chapman
AU - Anya Shindler
AU - Ashley E. Franks
AU - Sharon M. Tennant
AU - Wilbur H. Chen
AU - Mohamed Al-Ibrahim
AU - Jerry Kanellos
PY - 2026
DA - 2026/10/12
JO - Scientific Reports
DO - 10.1038/s41598-026-70974-9
UR - https://www.nature.com/articles/s41598-026-70974-9
AB - This study evaluated once-daily oral dosing of Travelan (IMM-124E), a bovine polyclonal antibody product, for prevention of Enterotoxigenic Escherichia coli (ETEC)-induced diarrhoea. In this randomised, double-blind, placebo-controlled trial using an ETEC-controlled human infection model, 60 healthy subjects received 1200mg Travelan or placebo once-daily for 7 days. Two days after dosing commenced, subjects were challenged with ETEC strain H10407 and monitored for diarrhoeal symptoms. Travelan was well-tolerated with a significant 50% reduction in ETEC challenge-related adverse events ( P = 0.0001). Efficacy outcomes did not reach statistical significance, largely due to a lower-than-expected placebo attack rate (33% vs 70% anticipated); however a strong trend consistently favoured Travelan, including a 40% reduction in moderate-to-severe diarrhoea (primary endpoint), a 50% reduction in severe diarrhoea, a 44% reduction in all diarrhoea, and a 71% reduction in early antibiotic use. These findings were supported by significant reductions in intestinal inflammation markers (faecal myeloperoxidase and calprotectin) 4 days post-challenge. Significantly lower O78 lipopolysaccharide IgA and IgG titers were observed but over 80% of subjects in each group seroconverted by day 15–29, indicating Travelan did not hinder immunity to ETEC. Although underpowered and limiting definitive interpretation, these findings suggest a potential protective effect of once-daily Travelan, warranting further investigation in a larger adequately powered trial.
SN - 2045-2322
ER -