A clinical phase-I study of the company’s new oral traveler’s diarrhea vaccine was recently successfully completed. A prototype version of the vaccine containing inactivated E. coli bacteria and the hybrid protein LCTBA was studied for safety and immunogenicity. A reference vaccine containing components of a previously studied vaccine was used as comparator. The study was conducted in 60 healthy volunteers in collaboration with scientists at the University of Gothenburg, Sweden and the non-profit organization PATH Vaccine Solution. The primary objectives of the study were met. The vaccine was shown to be safe and well tolerated by the study participants. Side effects were generally mild and comparable to what was observed with the reference vaccine. The prototype vaccine also elicited an intestinal immune response to the vaccine components, in line with what is expected for a protective effect.
The results are very encouraging. A new clinical phase-I study to document the safety and immunogenicity of the final composition vaccine has been initiated.
Traveler’s diarrhea is the leading cause of illness among international travelers to developing countries. Enterotoxigenic Escherichia coli (ETEC) bacteria are the primary cause of this disease. Among the estimated 60 million travelers from industrialized countries to high-risk areas in the developing world, as many as 50% may experience at least one TD episode during their journey. ETEC is usually responsible for 22-60% of all TD cases in both civilian and military groups or about 7-18 million cases per year. ETEC is also a major cause of diarrheal disease in children living in endemic countries leading to 400 million diarrheal episodes and approximately 300 000 death per year.
“It is very rewarding to develop a brand new vaccine with potential to save lives of children in developing countries and at the same time reduce the risk of traveler’s diarrhea in travelers to such areas. The positive results obtained in this study encourage us to speed up the clinical development program,” says Medical Director Björn Gustafsson
Scandinavian Biopharma is a Swedish research-based biotech company engaged in marketing and sales of vaccines, dental products and immunoglobulins to the Nordic market.
Research and development is mainly focused on development of a new oral traveler’s diarrhea vaccine in collaboration with PATH Vaccine Solutions and University of Gothenburg.