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 The study is conducted in collaboration with scientists at the University of Gothenburg, Sweden and the non-profit organization PATH Vaccine Solution.
Traveler’s diarrhea is usually a consequence of ingesting food or water contaminated with enterotoxigenic E. coli bacteria. Once in the intestine, the bacteria start to multiply on the mucosal surface. Toxins produced by the bacteria cause diarrhea. The vaccine is designed to stimulate production of antibodies both to surface structures on the bacteria, and to the heat-labile toxin produced by the bacteria. This dual line-type of defense will protect both from colonization of the gut with bacteria and by neutralization of the toxin.
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 study included 60 healthy volunteers and a reference vaccine containing components of a previously studied vaccine was used as comparator. The primary objectives of the study were met. In the published study the prototype vaccine was found 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 a dose-dependent intestinal immune response to the vaccine components.
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.
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 conducted through the subsidiary ETVAX and is mainly focused on development of a new oral traveler’s diarrhea vaccine in collaboration with PATH Vaccine Solutions and University of Gothenburg.
For more information, please contact
Björn Sjöstrand, CEO, cell phone: +46 727-125 120
Nils Carlin, VP Research, cell phone: +46 701-85 10 62
Björn Gustafsson, VP Medical, cell phone: +46 701-85 12 47