Scandinavian Biopharma through its subsidiary ETVAX continues clinical development
A clinical phase-I, randomized, placebo controlled, double-blinded study of the final composition vaccine, comprising 120 healthy volunteers is presently ongoing (study # OEV-121). All volunteers have been fully immunized and immunological analyses are ongoing. The study is designed to measure safety and immunogenicity of the vaccine when given either alone or in combination with the immune-enhancing adjuvant dmLT.
This final version of the Traveler’s diarrhea vaccine contains four different strains of E. coli covering about 80% of all clinical isolates worldwide, and the hybrid protein LCTBA.
Results from an earlier clinical study of the company’s prototype version of the vaccine were recently published in the scientific journal Vaccine by A. Lundgren and coworkers (http://dx.doi.org/10.1016/j.vaccine.2012.12.063). The prototype vaccine was found to be safe and well tolerated by the study participants.