Children’s Diarrhea Vaccine From Sweden Found Safe and Immunogenic

The oral inactivated vaccine candidate ETVAX was found safe and broadly immunogenic against enterotoxigenic E. coli diarrhea in children from 6 months to 5 years of age.

The results from this phase I/II study conducted by researchers at the University of Gothenburg was announced in The Lancet Infectious Diseases on November 20, 2019, saying ‘all predefined primary endpoints for the study were achieved and ETVAX stimulated immune responses to all key vaccine components.’

The researchers found ‘giving the ETVAX vaccine with an adjuvant enhanced the magnitude, breadth, and kinetics of the intestinal immune responses in infants.

This is important news since there is not a commercially available, preventive vaccine against Enterotoxigenic E. coli (ETEC) bacteria, which are a primary cause of diarrhea.

The ETVAX vaccine consists of inactivated E. coli bacteria expressing high levels of protective antigens and the ETEC-based B subunit protein LCTBA.

This clinical study examined the administration of ETVAX, given alone or together with different doses of an adjuvant, double-mutant heat-labile toxin (dmLT), to assess the vaccine's safety and immunogenicity in 450 children.

In addition to safety analyses, immune responses were determined by measuring the number of antibodies produced in the intestine (feces) as well as antibodies secreted by lymphocytes circulating in the blood to the intestine.

The study was conducted in Dhaka, Bangladesh, as a collaborative effort between the Sahlgrenska Academy at the University of Gothenburg, along with Scandinavian Biopharma, and the non-profit global health organization, PATH.

These new results confirm and extend the promising data previously reported from ETVAX trials in Swedish and Bangladeshi adults. 

Based on the results of this trial, advanced studies were initiated in September 2019 to further test safety, immune responses and protection of ETVAX (including dmLT) in African children 6-23 months of age.

An additional study evaluating the protective efficacy of ETVAX in Finnish travelers to Africa will be completed by the end of the first quarter of 2020.

Antibiotics can shorten the duration of diarrhea illness, especially if given early, but they are usually not required, says the US Centers for Disease Control and Prevention (CDC).

Because resistance to antibiotics is increasing worldwide, the decision to use an antibiotic should be carefully weighed against the severity of illness and the risk of adverse reactions, such as rash, antibiotic-associated colitis, and vaginal yeast infection.

Virtually all persons recover completely without any long-term consequences.

Furthermore, pregnant women and persons with weakened immune systems, such as patients who are receiving chemotherapy, who are taking immunosuppressive medications, or who have HIV infection, should talk with their healthcare provider if they are traveling to areas at high risk for ETEC exposure, says the CDC.

Despite the frequency of Traveler's Diarrhea, there is no international consensus on its prevention. But, the CDC says you can take steps to avoid traveler’s diarrhea, such as:

• Choose food and drinks carefully:  Eat only foods that are cooked and served hot. Avoid food that has been sitting on a buffet. Eat raw fruits and vegetables only if you have washed them in clean water or peeled them. 
• Only drink beverages from factory-sealed containers, and avoid ice because it may have been made from unclean water.
• Wash your hands:  Wash your hands often with soap and water, especially after using the bathroom and before eating. 
• If soap and water aren’t available, use an alcohol-based hand sanitizer. 
• In general, it’s a good idea to keep your hands away from your mouth.

Many international travelers ask ‘if the oral cholera vaccine is recommended to prevent traveler’s diarrhea.’

According to various studies and randomized controlled trials evaluating the oral cholera vaccine, they did not show a benefit and do not recommend its routine use to prevent Travelers Diarrhea, said the CDC during October 2019.

Traveller's Diarrhea news published by Vax-Before-Travel