Phase I Amount
$1,427,022
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.
