Scandinavian Biopharma announces successful results in placebo-controlled Phase I study of an oral, inactivated vaccine against diarrhea for travelers and children in developing countries
Travelers’ 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. About 65 million people travel from industrialized countries to high-risk areas in the developing world. Of these, 30 to 50 percent, or approximately 27 million people, may experience at least one travelers’ diarrhea episode during their journey.1 ETEC is also a major cause of diarrheal disease among children living in endemic countries, leading to as many as 400 million diarrheal episodes and approximately 300,000 deaths per year.2 Today there is no ETEC vaccine available on the market.
A clinical Phase I study of a novel vaccine against diarrhea caused by ETEC has been successfully completed. All primary endpoints were achieved. The vaccine was safe and well tolerated by the study participants. Adverse events were few and generally mild. No difference was observed in subjects receiving active substance or a placebo preparation.
In total, 75 percent of the subjects responded to all 5 of the primary vaccine components, a result that exceeds the primary immunological endpoint for the study (at least 50 percent of the subjects responding to at least 4 of the primary vaccine antigens). Furthermore, 85 percent of subjects receiving the vaccine coadministered with low dose adjuvant showed significant immune responses to all vaccine components. In addition to showing excellent safety and immunogenicity of the five-component vaccine, the results also confirm previous clinical results obtained with a prototype version of this vaccine.
The vaccine, consisting of four inactivated E. coli strains and the ETEC-based B subunit protein LCTBA, was studied for safety and immunogenicity in a total of 129 healthy adult volunteers. The study was designed as a four-armed, double-blinded, placebo-controlled trial. Study participants were randomized to receive two oral doses, two weeks apart of either the vaccine alone, vaccine co-administered with an oral adjuvant (LTR192G/L211A) in a low or a higher dose, or an inactive placebo preparation. In addition to safety parameters, antibodies directed to various vaccine components in fecal samples or produced by intestine-derived peripheral blood lymphocytes were measured at different time intervals.
This study was conducted at the University of Gothenburg as a collaborative effort between Scandinavian Biopharma, the University of Gothenburg Vaccine Research Institute, and the global health nonprofit organization, PATH. Data are still being analyzed, and the complete results will be presented at the International Conference on Mucosal Vaccines, Adjuvants & Delivery, 25-27 September 2013 in Copenhagen, Denmark, and at the 7th International Conference on Vaccines for Enteric Diseases, 6-8 November 2013 in Bangkok, Thailand.
Based on these very encouraging results, additional clinical studies are planned to document the vaccine’s protective efficacy in travelers, and to study the safety and immunogenicity of the vaccine when given to children living in ETEC-endemic areas.
Recently published results from the Global Enteric Multicenter Study on diarrheal diseases in developing countries, enrolling more than 20,000 children from seven sites across Asia and Africa, confirm that ETEC remain as one of the top four most important pathogens in children below 5 years of age.3
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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 ETEC vaccine in collaboration with PATH and the University of Gothenburg.
1. Wang M, et al. Economic aspects of travelers’ diarrhea. Journal of Travel Medicine. 2008;15(2):110–118.
2. World Health Organization (WHO). Weekly Epidemiological Record. Geneva, Switzerland: WHO; 2006; 81:97-104.
3. Kotloff K., et al. Burden and aetiology of diarrhoeal disease in infants and young children In developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet May 14, 2013.