Neisseria meningitidis compositions and methods thereof

Patent metadata

Field	Value
Publication number	US-10899802-B2
Application number	US-201715728610-A
Country	US
Kind code	B2
Filing date	Oct 10, 2017
Priority date	Sep 8, 2013
Publication date	Jan 26, 2021
Grant date	Jan 26, 2021

Abstract

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.

First claim

What is claimed is:

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.

Assignees

• Pfizer

Inventors

• Anderson Annaliesa Sybil
• Arumugham Rasappa Gounder
• Farley John Erwin
• Fletcher Leah Diane
• Harris Shannon Lea
• Jansen Kathrin Ute
• Jones Thomas Richard
• Khandke Lakshmi
• Loun Bounthon
• Perez John Lance
• Zlotnick Gary Warren

Classifications

• C07K14/22 Primary

  from Neisseriaceae (F) · CPC title

• A61K39/095 Primary

  Neisseria · CPC title

• C12N2770/32634

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N2710/20034

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• C12N7/00

  Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) · CPC title