Patent
In one aspect, the invention relates to a composition including a first polypeptide having the sequence set forth in SEQ ID NO: 1 and a second polypeptide having the sequence set forth in SEQ ID NO: 2. In one embodiment, the composition includes about 120 μg/ml of a first polypeptide including the amino acid sequence set forth in SEQ ID NO: 1, 120 μg/ml of a second polypeptide including the amino acid sequence set forth in SEQ ID NO: 2, about 2.8 molar ratio polysorbate-80 to the first polypeptide, about 2.8 molar ratio polysorbate-80 to the second polypeptide, about 0.5 mg/ml aluminum, about 10 mM histidine, and about 150 mM sodium chloride. In one embodiment, a dose of the composition is about 0.5 ml in total volume. In one embodiment, two-doses of the composition induce a bactericidal titer against diverse heterologous subfamily A and subfamily B strains in a human.
1. A liquid composition comprising
a) a first lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 1, and
b) a second lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2,
wherein the composition does not comprise a fusion protein; wherein the composition further comprises polysorbate-80.
2. The composition according to claim 1 , further comprising aluminum, histidine, and sodium chloride.
3. The composition according to claim 2 , wherein the composition comprises about 120 μg/ml of the first polypeptide; about 120 μg/ml of the second polypeptide; about 2.8 molar ratio of polysorbate-80; about 0.5 mg/ml aluminum; about 10 mM histidine; and about 150 mM sodium chloride.
4. The composition according to claim 2 , wherein the composition comprises about 60 μg of the first polypeptide; about 60 μg of the second polypeptide; about 18 μg polysorbate-80; about 250 μg aluminum; about 780 μg histidine; and about 4380 μg sodium chloride, per 0.5 ml dose.
5. The composition according to claim 1 , wherein the composition does not further comprise a polypeptide having less than 100% sequence identity to SEQ ID NO: 1.
6. The composition according to claim 1 , wherein the first polypeptide has a total of 258 amino acids.
7. The composition according to claim 1 , wherein the first polypeptide comprises the amino acid sequence set forth in SEQ ID NO: 3 at the N-terminus of the polypeptide.
8. The composition according to claim 1 , wherein the composition does not further comprise a polypeptide having less than 100% sequence identity to SEQ ID NO: 2.
9. The composition according to claim 1 , wherein the second polypeptide has a total of 261 amino acids.
10. The composition according to claim 1 , wherein the second polypeptide comprises the amino acid sequence set forth in SEQ ID NO: 3 at the N-terminus of the polypeptide.
11. The composition according to claim 1 , wherein the composition comprises at most two lipidated polypeptides.
12. The composition according to claim 1 , wherein the first polypeptide consists of the amino acid sequence set forth in SEQ ID NO: 1.
13. The composition according to claim 1 , wherein the second polypeptide consists of the amino acid sequence set forth in SEQ ID NO: 2.
14. A liquid composition comprising a) a first lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 1, and b) a second lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2 , wherein the composition does not comprise a hybrid protein; wherein the composition further comprises polysorbate-80.
15. A liquid composition comprising a) a first lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 1, and b) a second lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2 , wherein the composition does not comprise a chimeric protein; wherein the composition further comprises polysorbate-80.
16. The composition according to claim 1 , wherein the composition is not lyophilized.