BERGEN, Norway, July 7 (World Daily Times) — An experimental oral vaccine against E. coli could one day help prevent severe diarrhea in children, after a phase 2b trial in The Gambia found it was safe and triggered immune responses in young children.
The randomized, placebo-controlled study, reported in The Lancet Infectious Diseases, enrolled about 5,000 children ages 6 to 18 months. Researchers said the vaccine, ETVAX, caused no vaccine-related serious adverse events and produced antibodies against ETEC colonization factors and heat-labile toxins.
Protection varied by analysis. The study reported 26.6% efficacy against the primary endpoint, 48.2% against moderate-to-severe ETEC diarrhea when co-pathogens were included, 80.6% in children without certain intestinal parasites, 67.8% when vaccination began before 9 months of age, and 21% against moderate-to-severe diarrhea from any cause.
The study authors said the results were the first demonstration of protective efficacy by ETVAX in young children at risk and said they support a larger multicountry phase 3 trial. A peer-reviewed review on ETEC vaccine development says no licensed vaccine is available yet, while the bacterium remains a major cause of childhood diarrhea in low-income settings.
