Evaluation of efficacy, safety and stability of a novel adjuvant system in conventional and advanced vaccine platform technologies for use with various antigens in swine vaccines

摘要

Vaccine platform technologies for next generation biologic medicinal products have evolved quickly both in the elements used to construct the vaccine platforms but also in the strategies for delivery to the immune system of both animals and humans. Tomeet the demands of efficacy, safety, and potency needs of herd management and next generation biologies, adjuvant systems will also need to evolve in both research and product development. VaxLiant~R, Inc. has a novel adjuvant system that satisfies theversatility of the next generation of biologies, as well as, for optimizing response to conventional vaccines such as conventional killed swine influenza virus (SIV). SIV vaccines that have been prepared for use in pigs were shown to increase in HAI response when formulations were optimized using Vax-Liant~R adjuvant components. This adjuvant system has been used with a variety of vaccine platforms and infectious disease models for use in autogenous, conditional, or fully licensed swine vaccines. The adjuvant system does not use any oil and water format, aluminum hydryoxide, surfactant, or other harsh detergent that can irritate the site of inoculation. Instead, the vaccine uses an amphipatic lipid that is emulsified with a bioadhesive polymet using microfluidics technology; the formulations can be used in vitro to analyze stimulation of immune signals in cultured cells, as well as polarizing the immune response in animal models. Features of the adjuvant system, determined during the optimization ofits use with SIV vaccines, include the potential for great breadth and utilization in the vaccine industry.