Faculty and Staff Publications
Language
English
Publication Date
12-31-2023
Journal
Microorganisms
DOI
10.3390/microorganisms12010090
PMID
38257916
PMCID
PMC10819518
PubMedCentral® Posted Date
12-31-2023
PubMedCentral® Full Text Version
Post-print
Abstract
For the first time in over 20 years, an Enterotoxigenic Escherichia coli (ETEC) vaccine candidate, ETVAX®, has advanced into a phase 2b field efficacy trial for children 6-18 months of age in a low-income country. ETVAX® is an inactivated whole cell vaccine that has gone through a series of clinical trials to provide a rationale for the design elements of the Phase 2b trial. This trial is now underway in The Gambia and will be a precursor to an upcoming pivotal phase 3 trial. To reach this point, numerous findings were brought together to define factors such as safe and immunogenic doses for children, and the possible benefit of a mucosal adjuvant, double mutant labile toxin (dmLT). Considering the promising but still underexplored potential of inactivated whole cells in oral vaccination, we present a perspective compiling key observations from past ETVAX® trials that informed The Gambian trial design. This report will update the trial's status and explore future directions for ETEC vaccine trials. Our aim is to provide not only an update on the most advanced ETEC vaccine candidate but also to offer insights beneficial for the development of other much-needed oral whole-cell vaccines against enteric and other pathogens.
Keywords
Enterotoxigenic Escherichia coli, ETEC, ETVAX, vaccine, efficacy, The Gambia
Published Open-Access
yes
Recommended Citation
Hossain, M Jahangir; Svennerholm, Ann-Mari; Carlin, Nils; et al., "A Perspective on the Strategy for Advancing ETVAX, An Anti-ETEC Diarrheal Disease Vaccine, into a Field Efficacy Trial in Gambian Children: Rationale, Challenges, Lessons Learned, and Future Directions" (2023). Faculty and Staff Publications. 11.
https://digitalcommons.library.tmc.edu/ethics_pub/11