Compositions comprising three ospa fusion proteins for medical use

A composition comprising:

• (a) a first fusion protein comprising the amino acid sequence of SEQ ID NO:
• 1 (Lip-S1D1-S2D1);
• (b) a second fusion protein comprising the amino acid sequence of SEQ ID NO:
• 2 (Lip-S4D1-S3hybD1);
• and
• (c) a third fusion protein comprising the amino acid sequence of SEQ ID NO:
• 3 (Lip-S5D1-S6D1),
• wherein the composition comprises two or more doses,
• wherein:
• (1) each dose of the composition comprises a total protein content of the three fusion proteins of 135 to 200 μg for administration to a human adult;
• or
• (2) each dose of the composition comprises a total protein content of the three fusion proteins of 60 to 100 μg for administration to a human child,
• wherein each dose of the composition comprises the first, second, and third fusion proteins in a weight ratio of 1:2:1, 1:3:1, 1:1:2, 1:1:3, 1:2:2, 1:2:3, 1:3:2, 1:3:3, 2:1:1, 2:1:2, 2:1:3, 2:2:3, 2:2:1, 2:3:1, 2:3:2, 2:3:3, 3:1:1, 3:1:2, 3:1:3, 3:2:1, 3:2:2, 3:2:3, 3:3:1, or 3:3:2.

A composition comprising:

• (a) a first fusion protein comprising the amino acid sequence of SEQ ID NO:
• 1 (Lip-S1D1-S2D1);
• (b) a second fusion protein comprising the amino acid sequence of SEQ ID NO:
• 2 (Lip-S4D1-S3hybD1);
• and
• (c) a third fusion protein comprising the amino acid sequence of SEQ ID NO:
• 3 (Lip-S5D1-S6D1),
• wherein the composition comprises two or more doses, each dose comprising, in a volume of 0.5 mL:
• the three fusion proteins at a 1:1:1 weight ratio, between 5 mM and 50 mM sodium phosphate, between 100 and 200 mM sodium chloride, between 5 mM and 25 mM L-methionine, between 2.5% and 10% sucrose, between 0.01% and 0.1% polysorbate 20 and between 0.1% and 0.2% (w/v) aluminium hydroxide,
• and wherein:
• (1) each dose of the composition comprises a total protein content of the three fusion proteins of 135 to 200 μg for administration to a human adult;
• or
• (2) each dose of the composition comprises a total protein content of the three fusion proteins of 60 to 100 μg for administration to a human child.

A method of eliciting an immune response against Lyme disease in a human adult or human child, comprising administering to the human adult or human child a primary immunization series and two or more booster doses of a composition comprising:

• (a) a first fusion protein comprising the amino acid sequence of SEQ ID NO:
• 1 (Lip-S1D1-S2D1),
• (b) a second fusion protein comprising the amino acid sequence of SEQ ID NO:
• 2 (Lip-S4D1-S3hybD1), and
• (c) a third fusion protein comprising the amino acid sequence of SEQ ID NO:
• 3 (Lip-S5D1-S6D1),
• wherein each dose of the composition comprises, in a volume of 0.5 mL, the three fusion proteins at a 1:1:1 weight ratio,
• wherein:
• (1) each dose of the composition comprises a total protein content of the three fusion proteins of 135 to 200 μg when administered to the human adult;
• or
• (2) each dose of the composition comprises a total protein content of the three fusion proteins of 60 to 100 μg when administered to the human child,
• wherein the primary immunization series comprises administering at least two or at least three doses of the composition, and the two or more booster doses are administered every year after the last primary immunization or at the beginning of each tick season.