PRECLINICAL DEVELOPMENT OF SEMISYNTHETIC SAPONIN IMMUNOLOGICAL ADJUVANT TITERQUIL-1055 IN THE CONTEXT OF AN INFLUENZA VACCINE.

Increasingly defined vaccines against infectious diseases are better tolerated but less immunogenic, requiring use of an immunological adjuvant for best effect. Adjuvance's semi-synthetic saponin adjuvant TiterQuil-1055 (TQL1055) has shown remarkable efficacy with a variety of antigens with no detectable reactogenicity. When combined with 3 of the leading vaccines against influenza (Fluzone, Fluarix and Flublok) striking augmentation of the antibody response against the A/H3N2 hemagglutinin (HA) antigen and more than 4-fold vaccine dose saving was seen with all 3 vaccines but this was most striking with the most defined and least immunogenic vaccine, Flublok. The objectives of this Phase 1 proposal are 1) to determine if this augmentation applies to the other 2 antigens in Flu vaccines, A/H1N1 and B; 2) to determine if it applies to the T-cell responses, 3) to conduct an IND enabling stability study of Flublok/1055 and 4) to determine whether mixture of TQL1055 and Flublok with additional immunological adjuvants further augments the serologic or especially T-cell response to the HA antigen. Successful completion of this study will support initiation of IND enabling studies in a Phase 2 SBIR application for Flublok plus TQL1055 and use of TiterQuil-1055 with other types of vaccines.