The objective of this study is to demonstrate the efficacy and broad applicability of the human immune-modulating alphaGal Adjuvant Technology for antiviral vaccine development. We will use viral vaccine candidates for the select Category A viral pathogens Zaire ebolavirus (ZEBOV, filovirus), Rift Valley fever virus (RVFV, bunyavirus), and Lassa virus (LV, arenavirus), to evaluate the adjuvant potency of the alphaGal Adjuvant Technology. This technology is based on the innate naturally acquired human immune response to galactose alpha(1,3)galactose alpha(1,4)N-acetylglucosamine (alphaGal) epitopes. In Phase I we will illustrate the broad application of the alphaGal Adjuvant Technology to antiviral vaccines by demonstrating that alphaGal-modification significantly enhances and modulates the immune response to select vaccines in a mouse model. In the Phase I Option, the optimized adjuvant conditions eliciting the best immune response to the different tested antiviral vaccines, based upon the mouse model immunological data, will be utilized in limited lethal challenge efficacy experiments to be conducted with wild-type virus under Biosafety Level (BSL)-4 conditions in the mouse model. Significant efficacy will lead to a Phase II proposal and further studies involving adjuvant efficacy in small rodents and non-human primates.
Keywords: Adjuvant, Alphagal Technology, High Risk Viral Pathogens, Filovirus, Antiviral Vaccine, Broadly Applicable, Biodefense, Hemorrhagic Fever Virus
