BERGEN, Norway, July 7 (World Daily Times) — An experimental oral vaccine against enterotoxigenic Escherichia coli, a major cause of severe childhood diarrhea, protected some young children in a trial in The Gambia and caused no vaccine-related serious adverse events, researchers reported.
The randomized, placebo-controlled phase 2b study tested ETVAX in about 5,000 children ages 6 to 18 months. The researchers said the vaccine also triggered immune responses, including 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% when children with certain intestinal parasites were excluded, 67.8% when vaccination started before 9 months of age, and 21% against moderate-to-severe diarrhea from any cause.
The authors described the findings as the first demonstration of protective efficacy by ETVAX in young children at risk and said they support a larger, multicountry phase 3 trial in infants from low- and middle-income countries. A peer-reviewed review in PMC said no licensed ETEC vaccine is available.
ETEC is described in the review literature as a major global cause of childhood diarrhea in low-income settings, and the new trial adds to efforts to develop a vaccine for the bacterium.
