BERGEN, Norway, July 7 (World Daily Times) — A vaccine designed to block a common cause of severe childhood diarrhea could eventually protect young children, but researchers say the shot is still experimental and no ETEC vaccine is licensed for use yet.
The oral vaccine, called ETVAX, was tested in a randomized, placebo-controlled phase 2b trial involving about 5,000 children ages 6 to 18 months in The Gambia, according to the study published in The Lancet Infectious Diseases.
Researchers said the trial found no vaccine-related serious adverse events and that ETVAX produced immune responses against enterotoxigenic Escherichia coli, or ETEC, the bacterium it targets.
The study reported 26.6% protection against its primary endpoint. In other analyses, it found 48.2% protection against moderate-to-severe ETEC diarrhea when co-pathogens were included, 80.6% protection when children with certain intestinal parasites were excluded, and 67.8% protection when vaccination started before 9 months of age.
The researchers also reported 21% protection against moderate-to-severe diarrhea from any cause. They described the results as the first demonstration of protective efficacy by ETVAX in young children at risk and said the findings support a larger, multicountry phase 3 trial.
ETEC remains a major cause of childhood diarrhea in low-income settings, according to peer-reviewed reviews, and the study authors said the vaccine’s next step is broader testing before it could be considered for public use.
