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

Vaccine
Clayton HarroMichael Darsley

Abstract

There is no licensed vaccine against enterotoxigenic Escherichia coli (ETEC), a major cause of diarrhea-associated morbidity and mortality among infants and children in low-income countries and travelers. The results of this vaccination/challenge study demonstrate strong protection by an attenuated ETEC vaccine candidate, ACE527, when co-administered with a mucosal adjuvant, the double-mutant heat-labile toxin (dmLT) of ETEC. Sixty healthy adults participated in a randomized, placebo-controlled, double-blind study with three doses of lyophilized ACE527 (∼3 × 109 of each strain per dose) administered orally with or without dmLT adjuvant (25 µg/dose). Six months later, 36 of these volunteers and a control group of 21 unvaccinated volunteers were challenged with virulent ETEC strain H10407. The primary outcome was severe diarrhea, defined as passing >800 g of unformed stools during the inpatient period following challenge. The vaccine was well tolerated and induced robust immune responses to key antigens. The protective efficacy (PE) against the primary outcome of severe diarrhea was 65.9% (95% confidence interval [CI] 5.4-87.7, p = 0.003). Among subjects receiving the adjuvanted vaccine, the attack rate of severe diarrhea was 23....Continue Reading

Citations

Jul 31, 2019·Current Opinion in Infectious Diseases·Lorne SchweitzerMichael Libman
Feb 23, 2020·Journal of Pediatric Gastroenterology and Nutrition·Alfredo GuarinoSuporn Treepongkaruna
Jun 20, 2020·Gut Microbes·Hyesuk SeoWeiping Zhang
Dec 31, 2020·Vaccines·Hans Van der WekenBert Devriendt
Dec 3, 2020·International Journal of Molecular Sciences·Shiqi LiuSebastian A J Zaat
Jul 3, 2021·Microorganisms·Richard WalkerLouis Bourgeois
Jul 28, 2021·Nature Reviews. Immunology·Ed C Lavelle, Ross W Ward

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Methods Mentioned

BETA
ELISA

Software Mentioned

SAS®

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