MSI proposes to use its novel and proprietary polymer chemistry for preparing carbohydrate-protein conjugates to develop a Streptococcus pneumoniac vaccine that is effective in children under 2 years old. Children of this age face significant risk of morbidity and mortality from S. pneumoniae respiratory infections, but they are unable to respond to commercial vaccines that are effective in older children. An effective vaccine should contain at least 7-10 of the 84 capsular polysaccharide serotypes that account for most serious pneumococcal infections. MSI has demonstrated that it can prepare conjugates that are more immunogenic for both the polysaccharide and protein components than are conjugates prepared by conventional methods. Our process is simpler, faster, more efficient and reproducible, and more cost-effective than other methods, and may help overcome some of the complexities of developing a multivalent conjugate vaccine. Therefore, the specific objectives of this Phase I project are to prepare conjugates of a representative set of S. pneumoniae serotypes, measure-their immunogenicity individually in mice, and characterize the biological function of the induced antibodies in vitro. We anticipate that this work will lead to a Phase II proposal to prepare and test a candidate combined formulation in one or more animal species.Proposed commercial application:MSI's polymer-based conjugation technology offers significant manufacturing advantages for conjugate vaccines. Human vaccines represent a $3 billion global market, of which efficacious pneumococcal pneumonia vaccines for infants represent an estimated $300-400 million. The total market for conjugate vaccines, including Hib, pneumococcus and meningococcus represents the fastest growing segment of the vaccine market and has a potential valuation of $1 b lion.National Institute of Allergy and Infectious Diseases (NIAID)
