A new vaccine candidate designed to protect against one of the world’s leading causes of diarrhoeal disease has demonstrated strong efficacy in a phase IIb clinical trial conducted in The Gambia.
The oral vaccine, ETVAX, targets enterotoxigenic E. coli (ETEC), a common gastrointestinal pathogen that is a major cause of diarrhoeal disease in young children in low- and middle-income countries such as Nigeria and the most common cause of travellers’ diarrhoea.
The phase IIb study, funded by European & Developing Countries Clinical Trials Partnership, Phase 2 (EDCTP2), assessed the safety and efficacy of ETVAX in 4,936 young children aged 6-18 months across different regions of The Gambia. In the randomised, double-blind, placebo-controlled trial, participants received a three-dose regimen of either ETVAC or placebo and were followed for up to 24 months.
Key findings showed that the vaccine reduces ETEC-positive moderate-to-severe diarrhoea, irrespective of co-infections by pproximately 50% .
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It also showed 81% vaccine efficacy against ETEC-positive moderate-to-severe diarrhoea when enteroparasitic co-infections were excluded; 68% vaccine efficacy among children vaccinated before nine months of age, highlighting the importance of early vaccination;
And a 21% reduction in all-cause moderate-to-severe diarrhoea over the 24-month follow-up period.
ETVAX is currently the most advanced ETEC vaccine candidate in clinical development. It is formulated to provide coverage against more than 90% of circulating ETEC strains in high-burden settings.
“We are proud to see this project reach such an important milestone. These results provide a critical foundation for advancing into a phase III study and, if successful, will bring us closer to delivering a much-needed new vaccine to prevent diarrhoeal disease.” Debora Bade, Project Office, EDCTP Association
A major cause of childhood illness said in a statement.
The vaccine is now considered phase III-ready for the prevention of moderate-to-severe ETEC diarrhoea in infants and young children in low- and middle-income countries.
If phase III trials confirm these findings and regulatory approval is achieved, ETVAX could become an important new tool for reducing ETEC-related diarrhoea in high-burden settings and help prevent long-term developmental impacts associated with repeated diarrhoeal episodes in early childhood.
