Impressive results in new Vaccine publication
Although ETEC is the most frequent bacterial cause of diarrhea in children in developing countries and the major cause of travelers’ diarrhea, no vaccine is yet available against ETEC disease. In a recently published article in Vaccine the clinical phase I results with our new oral vaccine against ETEC is presented. The objectives of this study were to evaluate the safety and mucosal immunogenicity of the vaccine and to explore if the immunogenicity of the vaccine might be further enhanced by addition of double-mutant heat-labile toxin (dmLT) adjuvant.
The results show that the vaccine was safe, well tolerated and broadly immunogenic – a result that highly exceeded the expectations. Based on the excellent safety profile and the capacity of the vaccine to induce highly significant mucosal immune responses against the most prevalent ETEC virulence factors, the vaccine will be tested for safety and immunogenicity in different age groups including infants in Phase I/II trials in Bangladesh during next year and for protective efficacy in travelers/visitors to ETEC-endemic areas the year after.
The full text article can be found on doi:10.1016/j.vaccine.2014.10.069.