The University of Gothenburg Vaccine Research Institute announced on Wednesday that it has seen successful results in a placebo controlled phase 1 study of an oral vaccine used to treat diarrhea.
Diarrhea is a serious medical issues for children in low- and middle-income countries. There are more than 400 million cases of diarrhea among children in these countries and approximately 300,000 children die from diarrhea each year.
Enterotoxigenic Escherichia coli bacteria is the main cause of diarrhea in children, as well as the leading cause of illness among international travelers who visit these countries. Of the 65 million people traveling to these counties, 30 to 50 percent will contract ETEC and have diarrhea.
The new oral ETEC vaccine, which was developed in Sweden, prevents the patient from contracting ETEC. The now completed clinical phase 1 trial shows that the vaccine is safe and is also strongly immunogenic, although a few minor adverse reactions were found in some patients.
The study showed that 85 percent of the people who received the vaccine with low dose adjuvant showed significant immune responses to all the vaccine components. These results also confirmed previous preclinical results, as well as other clinical results that were obtained with a prototype vaccine.