Results from preclinical evaluation of the new multivalent, oral Traveler’s diarrhea vaccine was recently published. The vaccine, consisting of four inactivated E. coli strains and the ETEC-based B subunit protein LCTBA, was studied for immunogenicity and safety in mice. The optional co-administration of the vaccine with a nontoxic oral adjuvant (dmLT) was also studied. The vaccine was well tolerated and induced a strong intestinal immune response to all vaccine components. The mucosal response was further enhanced when the vaccine was co-administered with the adjuvant.
Based on these results, and results from an earlier completed clinical study in humans with the prototype vaccine (published in Vaccine 2013;31:1163-1170), a clinical phase I study in Swedish adult volunteers is now ongoing to assess the reactogenicity and immunogenicity after two oral immunizations with the vaccine alone and with two different doses of the dmLT adjuvant (study # OEV-121).
The results from the animal studies are published in the peer-reviewed scientific journal Vaccine by Holmgren, J., et al. Development and preclinical evaluation of safety and immunogenicity of an oral ETEC vaccine containing inactivated E. coli bacteria overexpressing colonization factors CFA/I, CS3, CS5 and CS6 combined with a hybrid LT/CT B subunit antigen, administered alone and together with dmLT adjuvant. Vaccine. 2013, http://dx.doi.org/10.1016/j.vaccine.2013.03.027