Health and Me

Rachel V Thomas

Lancet study shows experimental oral E coli vaccine can help prevent diarrhea in children

An experimental oral vaccine has proven to be safe and effective in generating immunity against the Enterotoxigenic Escherichia coli (ETEC), responsible for 75 million diarrhea episodes and over 40,000 deaths annually in children worldwide, according to a new study published in the journal The Lancet Infectious Diseases.

The vaccine ETVAX -- an oral whole-cell vaccine for ETEC -- consists of inactivated E coli bacteria and is designed to prevent bacterial colonization.

In the phase 2 trial, including nearly 5,000 Gambian children aged 6-18 months, ETVAX was well tolerated. There was no increase in the frequency or severity of adverse events, said an international team of researchers, including those from the London School of Hygiene &amp; Tropical Medicine, in the paper. 

"Using active and passive surveillance, we confirmed that ETVAX is safe and induces immune responses to colonisation factors and heat-labile toxins," they added. 

Produced by ETEC, heat-labile toxins are sensitive to heat and cause watery diarrhea.

ETVAX showed to be safe, immunogenic, and also offered protection against moderate-to-severe ETEC diarrhea in the presence of co-pathogens. 

Importantly, the study provided the first evidence that ETVAX can significantly reduce the incidence of ETEC-positive and all-cause diarrhea, particularly when vaccination is initiated before age 9 months, and in children without concurrent enteroparasitic infections, the team said. 

“This study provides the first demonstration of induction of protective efficacy by ETVAX in young children who are at risk,” the researchers said. 

“These findings support progression to a large, multi-country, phase 3 trial to confirm ETVAX efficacy against ETEC disease in children and to support ETVAX introduction in high-burden settings,” they added.

These findings support advancing ETVAX to a pivotal phase 3 trial. 

The researchers enrolled children ages six to 18 months to receive ETVAX or a placebo at three timepoints (days 1, 15, and 90). 

Serious adverse events occurred in 1.0 percent of the ETVAX group and 1.3 percent of the placebo group, with none related to the vaccine.

Among the 122 children in whom immunity was assessed, the ETVAX, developed by Scandinavian Biopharma, increased antibodies to ETEC colonization factors and heat-labile toxins. 

Enterotoxigenic Escherichia coli (ETEC) is a pathogenic, toxin-producing strain of E. coli that specifically causes watery, non-bloody diarrhea, commonly known as traveler’s diarrhea. 

While most E. coli are harmless gut flora, ETEC uses adhesins to colonize the small intestine and release toxins, whereas "generic" E. coli is usually beneficial or benign. 

Annually, ETEC causes 220 million diarrhea episodes globally, with 75 million episodes and up to 42,000 deaths in children younger than 5 years, mainly occurring in low-income countries.

Even as climate models predict increased ETEC incidence under warming conditions, the researcher noted that "an ETEC vaccine could reduce illness and deaths, improve child growth, decrease health-care costs, and curb antimicrobial resistance".

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An experimental oral vaccine has proven to be safe and effective in generating immunity against the Enterotoxigenic Escherichia coli (ETEC), responsible for 75 million diarrhea episodes and over 40,000 deaths annually in children worldwide, according to a new study published in the journal The Lancet Infectious Diseases.  The vaccine ETVAX -- an oral whole-cell vaccine for ETEC -- consists of inactivated E coli bacteria and is designed to prevent bacterial colonization. In the phase 2 trial, including nearly 5,000 Gambian children aged 6-18 months, ETVAX was well tolerated. There was no increase in the frequency or severity of adverse events, said an international team of researchers, including those from the London School of Hygiene & Tropical Medicine, in the paper. "Using active and passive surveillance, we confirmed that ETVAX is safe and induces immune responses to colonisation factors and heat-labile toxins," they added. Produced by ETEC, heat-labile toxins are sensitive to heat and cause watery diarrhea.What did the study find?ETVAX showed to be safe, immunogenic, and also offered protection against moderate-to-severe ETEC diarrhea in the presence of co-pathogens. Importantly, the study provided the first evidence that ETVAX can significantly reduce the incidence of ETEC-positive and all-cause diarrhea, particularly when vaccination is initiated before age 9 months, and in children without concurrent enteroparasitic infections, the team said. “This study provides the first demonstration of induction of protective efficacy by ETVAX in young children who are at risk,” the researchers said. “These findings support progression to a large, multi-country, phase 3 trial to confirm ETVAX efficacy against ETEC disease in children and to support ETVAX introduction in high-burden settings,” they added. These findings support advancing ETVAX to a pivotal phase 3 trial. How was the study conducted?The researchers enrolled children ages six to 18 months to receive ETVAX or a placebo at three timepoints (days 1, 15, and 90). Serious adverse events occurred in 1.0 percent of the ETVAX group and 1.3 percent of the placebo group, with none related to the vaccine. Among the 122 children in whom immunity was assessed, the ETVAX, developed by Scandinavian Biopharma, increased antibodies to ETEC colonization factors and heat-labile toxins.  What is ETEC?Enterotoxigenic Escherichia coli (ETEC) is a pathogenic, toxin-producing strain of E. coli that specifically causes watery, non-bloody diarrhea, commonly known as traveler’s diarrhea. While most E. coli are harmless gut flora, ETEC uses adhesins to colonize the small intestine and release toxins, whereas "generic" E. coli is usually beneficial or benign.  Annually, ETEC causes 220 million diarrhea episodes globally, with 75 million episodes and up to 42,000 deaths in children younger than 5 years, mainly occurring in low-income countries.Even as climate models predict increased ETEC incidence under warming conditions, the researcher noted that "an ETEC vaccine could reduce illness and deaths, improve child growth, decrease health-care costs, and curb antimicrobial resistance".