Patent ID: 8889616

Claim:
A liposomal vaccine formulation comprising: (a) a peptide comprising: (SEQ ID NO: 2) H 2 N-TSAPDT(Tn)RPAPGS(Tn)T(Tn)APPAHGVTSAPDT(Tn) RPAPGS(Tn)T(Tn)APPAHGVS*S*L-OH or a sequence at least 95% identical to SEQ ID NO: 2; wherein * independently, at each occurrence, represents a lipid covalently attached to an amino acid residue and Tn represents GalNAcα1; (b) an adjuvant of Formula I: wherein at least one of R 1 , R 2 , R 3 , R 5 , R 6 , and R 7 is a strongly lipophilic group selected from the group consisting of wherein X, X 1 , X 2 , and X 3 are independently —CO— or —CH 2 —; Z is —NH— or —O; k, m, and r are independently an integer of 0 to 30 inclusive, n and q are independently an integer of 0 to 6 inclusive; wherein Y 4 is a spacer selected from the group consisting of —O—, —S—, and —NH— wherein, at least one of Y 1 R 1 , Y 2 R 2 , Y 3 R 3 , Y 5 R 5 , Y 6 R 6 and Y 7 R 7 is a monovalent phosphate equivalent (MPE), wherein each monovalent phosphate equivalent is, independently, (a) —R′—C(O)OH where R′ is a substituted or unsubstituted alkyl group of 1-4 carbons, or (b) selected independently from the group consisting of —OB(OH)OR, —OP(O)(OH)OR, —OS(0)(0)(OH)OR, and —OP(═O)(OH)—O—P(═O)(OH)OR, where R is hydrogen, or a substituted or unsubstituted alkyl group of 1-4 carbons, and if R is a substituted alkyl group, the substitutions are —OH or —NH 2 , wherein R 8 is selected from the group consisting of H, OH, OR 9 , a moiety which in combination with Y 8 forms a monovalent phosphate equivalent as previously defined, and a group (i)-(viii) as defined above; wherein R 9 is an alkyl or acyl group of 1 to 10 carbon length; and wherein the glycosidic linkage is α or β; or a pharmaceutically acceptable salt thereof; or an adjuvant of Formula II: wherein at least one of R 1 , R 2 , R 3 , R 11 , R 12 and R 13 is a strongly lipophilic group selected from the group consisting of (i)-(viii) above; wherein Y 4 is a spacer selected from the group consisting of —O—, —S—, and —NH— and wherein at least one of Y 1 R 1 , Y 2 R 2 , Y 3 R 3 , Y 11 R 11 , Y 12 R 12 and Y 13 R 13 is independently a monovalent phosphate equivalent as previously defined; wherein the following limitations apply to both (I) and (II) above: Y 1 , Y 2 , Y 3 , Y 5 , Y 6 , Y 7 , Y 11 , Y 12 and Y 13 are spacers independently selected from the group consisting of —O—, —S—, and —NH—; R 1 , R 2 , R 3 , R 5 , R 6 , R 7 , R 11 , R 12 and R 13 are independently hydrogen, a moiety which with the commonly numbered Y group forms monovalent phosphate equivalent as previously defined, or a strongly lipophilic group selected from the group consisting of (i)-(viii) above; the strongly lipophilic groups of said compound collectively provide at least two major carbon chains, and the major carbon chains of said strongly lipophilic groups collectively provide at least 30 carbon atoms; or a pharmaceutically salt thereof; and (c) one or more carrier lipids.