First-of-its-kind vaccine protects children from deadly intestinal infection
ETVAX is the first vaccine that provides significant protection against the pathogen e coli Among children
Scientists have developed a vaccine for its toxic form e coli Bacteria that cause diarrhea in children in low-income countries.
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enterotoxigenic infection Escherichia coli (ETEC) bacteria are the most common cause of travelers’ diarrhea, and they most commonly cause diarrhea in childhood in low-income areas. In children under five years of age, whose immune systems are still developing, infection can lead to malnutrition; They cause up to 42,000 deaths annually. Soon a vaccine may be available to prevent these infections.
In Lancet Infectious Diseases Last month, scientists shared results of the first study to evaluate the safety and efficacy of the ETEC-controlled vaccine in a large pediatric population in The Gambia. A vaccine called ETVAX is also one of these. many are in development To reduce ETEC infections in both adults and children. ETVAX provided immunity against pathogens and had no adverse side effects.
ETEC bacteria have “adhesion” proteins that enable them to attach to the intestinal mucosa. The bacteria then release toxins, causing watery diarrhea and stomach cramps. The risk increases due to lack of sanitation and access to clean drinking water in low-income countries. e coli Infections, resulting in more childhood deaths and higher health care costs.
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An approved oral cholera vaccine called Ducoral provides partial protection against some forms of ETEC diarrhea, but “currently, there is no approved” e coli Any type of vaccine available for protection e coli infection in humans,” says immunologist Ann-Marie Svennerholm of the University of Gothenburg in Sweden, who is a co-author of the study. She notes that ETVAX is the first to show significant protection against e coli Infection in people.
Svennerholm says oral cholera vaccines contain “only a few different types of bacteria” to be protective. In contrast, ETEC bacteria have 26 distinct adhesive proteins and two types of toxins. For ETVAX, his research team created a formula that used the four most common adhesive proteins, which are found in 80 percent of all enterotoxigenics. e coli. They combined the protein with an inactivated portion of a toxin and an ingredient that stimulates intestinal immune responses. ETVAX was made by Scandinavian Biopharma. Some authors of the study own commercial rights to the vaccine and may receive a small royalty if it eventually becomes a commercial product.
Previous studies found that ETVAX was safe and effective in small pediatric populations in Bangladesh zambia. (TL1) For the most recent trial, 4,936 children aged six to 18 months in The Gambia received three doses of either the oral vaccine or a placebo, followed by two years of follow-up. Researchers randomly assigned children to receive either the vaccine or a placebo, and the investigators did not know who received which.
ETVAX increased antibodies against several ETEC adhesin proteins, especially after the third dose. It reduced episodes of moderate to severe ETEC diarrhea by 26 percent compared with the placebo group when ETEC is co-infected with common gut pathogens. Shigella, Cryptosporidium, Rotavirus or a type of norovirus were excluded.
When researchers included these co-infections, ETVAX reduced moderate to severe diarrhea from ETEC by 48 percent in all children and by 68 percent in infants younger than nine months. This highlights the importance of vaccination of young infants who have not acquired natural immunity to enteric pathogens. Additionally, co-author Thomas Wirzba, professor of infectious diseases at Wake Forest School of Medicine, explains that ETVAX reduced moderate to severe diarrhea caused by viruses, bacteria or other parasites by 21 percent. This suggests that the vaccine provides partial protection against many enteric pathogens.
David Sacks, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health who was not involved in the paper, believes it is a “high-quality study” because it used a variety of outcomes to evaluate the vaccine. However, they noted that the mechanisms behind cross protection against other pathogens require further investigation. Amira Roes, a professor of global health and epidemiology at George Mason University’s College of Public Health, says the research supports future clinical trials, but further work is needed to better characterize the causes of diarrhea-related illnesses in participants.
ETVAX will soon be evaluated in a Phase 3 trial approved by the European Medicines Agency, enrolling 5,800 infants between six and nine months of age from low- and middle-income countries.
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