Oral vaccine for diarrhoea passes first trial

29 May 2013

A novel vaccine against four strains of E. coli has passed a phase I clinical trial, according to the University of Gothenburg Vaccine Research Institute (GUVAX).

The vaccine, consisting of four inactivated E. coli bacterial strains and the Enterotoxigenic Escherichia coli (ETEC) based B subunit protein LCTBA, was studied for safety and immunogenicity in a total of 129 healthy volunteers.

 Only few and mild adverse reactions observed, and strongly immunogenic, stimulating immune responses to all vaccine components.

ETEC bacteria are the primary cause of diarrhoea in children living in low and middle income countries result in 400 million diarrheal episodes and approximately 300 000 deaths among children per year. ETEC is also the leading cause of illness among international travellers to developing countries.

Among the 65 million people travelling from industrialized countries to ETEC high-risk areas in the developing world, 30-50 % (ca 30 million people) experience at least one TD episode during their journey. Today there is no ETEC vaccine available on the market for use in either children or travelers in ETEC high-risk areas.

This study was conducted at the Sahlgrenska Academy of University of Gothenburg as a collaborative effort between University of Gothenburg Vaccine Research Institute, Scandinavian Biopharma, Stockholm and the non-profit organization PATH, Washington D.C.

The results will be presented at the Mucosal Vaccines, Adjuvants and Delivery Conference in Copenhagen, September 25-27 2013 and 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 protective efficacy in travellers, and to study the safety and immunogenicity of the vaccine when given to children living in areas endemic for ETEC.