Wyeth

Yury Vladimirovich Matsuka

Lakshmi Khandke

Susan Kay Hoiseth

Michael Hagen

Steven Morris Baker

Elizabeth Teremy Anderson

Thomas Newell Metcalf, Iii

An isolated, altered fibronectin-binding protein (Fnb) ofhaving at least one mutation in an amino acid selected from residues corresponding to Gln103, Gln105, Lys157, Lys503, Lys620, Lys702, Lys762, Gln783 and Gln830 of FnbA ofstrain ATCC49525 is described. Replacement of these reactive residues within the fibronectin-binding protein renders this protein less capable than wild-type Fnb of covalently cross-linking with fibronectin and fibrin. The altered fibronectin-binding protein effectively interferes with adhesion ofto fibronectin and fibrin, and therefore, an immunogenic composition comprising such altered Fnb exhibits improved immunogenic properties and is safer to use.

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The present invention provides a method for producing a less-painful immunogenic composition of a hydrophobic protein in a pharmaceutically acceptable carrier suitable for administering to a mammal, comprising the steps of (a) solubilizing said hydrophobic protein with a zwitterionic detergent to make a first composition; (b) altering said first composition, such that the altered composition produces a reduction in pain as measured in the rat footpad model as compared to said first composition.

Formulations of hydrophobic proteins in an immunogenic composition having improved tolerability

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New Windsor, NY, United States of America

Yury Vladimirovich Matsuka