Own vaccine development

In collaboration with the international global health organization PATH and University of Gothenburg, development is focused on oral ETEC diarrhea vaccine. PATH is a product development partner of the Bill and Melinda Gates Foundation. Our vision is to successfully develop a vaccine to prevent and control ETEC-related illness and mortality among infants and young children living in ETEC-endemic areas, as well as to prevent ETEC-associated travelers’ diarrhea occurring among international travelers.

The vaccine is composed of a combination of a select set of inactivated E. coli bacteria and a hybrid toxoid protein. A recently conducted clinical Phase I study showed impressive results where all primary endpoints were exceeded. The vaccine candidate was safe and well tolerated by the study participants.  Successful development of this vaccine will meet an unmet medical need of travelers as well as children in developing countries, since there is presently no licensed vaccine against this disease.

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 65 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 countries endemic for ETEC, leading to over 400 million diarrheal episodes and approximately 300,000 deaths each year.

Etvax® is the registered trademark of Scandinavian Biopharma’s vaccine against diarrheal disease caused by ETEC. Etvax® is presently in Phase I/II clinical trials to document safety and efficacy in the most vulnerable children in which ETEC infection may cause life-threatening disease. Protective efficacy studies of the vaccine in western adults traveling to tropical risk areas are ongoing.

Four scientific articles regarding the vaccine development project have been published in the well reputed Vaccine journal. Below is the links to the articles.

  • A. Lundgren. 2014;32:7077-7084. Safety and immunogenicity of an improved oral inactivated multivalent enterotoxigenic Escherichia coli (ETEC) vaccine administered alone and together with dmLT adjuvant in a double-blind, randomized, placebo-controlled Phase I study. doi:10.1016/j.vaccine.2014.10.069
  • J. Holmgren. 2013;31:2457-2464. Development and preclinical evaluation of safety and immunogenicity of an oral ETEC vaccine containing inactivated E. coli bacteria over expressing colonization factors CFA/I, CS3, CS5 and CS6 combined with a hybrid LT/CT B subunit antigen, administered alone and together with dmLT adjuvant. http://dx.doi.org/10.1016/j.vaccine.2013.03.027
  • A. Lundgren. 2013;31:1163-1170. Clinical trial to evaluate safety and immunogenicity of an oral inactivated enterotoxigenic Escherichia coli prototype vaccine containing CFA/I over expressing bacteria and recombinantly produced LTB/CTB hybrid protein. http://dx.doi.org/10.1016/j.vaccine.2012.12.063
  • J. Tobias. 2011;29:8863-8869. Construction of a non-toxigenic Escherichia coli oral vaccine strain expressing large amounts of CS6 and inducing strong intestinal and serum anti-CS6 antibody responses in mice. http://dx.doi.org/10.1016/j.vaccine.2011.09.096

 This project has received funding from the European Union’s Horizon 2020 research and innovation programme