IP Library › Patent Application 17114802
Patent Application
App. No. 17/114,802

NEISSERIA MENINGITIDIS COMPOSITIONS AND METHODS THEREOF

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Patent No.
US None
App. No.
17/114,802
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.

Claims (16)

1 . A method for inducing a bactericidal immune response against a Neisseria meningitidis serogroup B subfamily A strain, and against a Neisseria meningitidis serogroup B subfamily B strain in a human subject, comprising administering an effective amount of a N. meningitidis rLP2086 composition wherein said N. meningitidis rLP2086 composition comprises 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 immune response is i) bactericidal against a N. meningitidis serogroup B subfamily A strain that is heterologous to a N. meningitidis strain expressing A05, and is ii) bactericidal against a N. meningitidis serogroup B subfamily B strain that is heterologous to a N. meningitidis strain expressing B01.

2 . The method according to claim 1 , wherein the immune response is bactericidal against a N. meningitidis serogroup B subfamily A strain that is heterologous to N. meningitidis strain M98250771.

3 . The method according to claim 1 , wherein the immune response is bactericidal against a N. meningitidis serogroup B subfamily B strain that is heterologous to N. meningitidis strain CDC1127.

4 . The method accordingly to claim 1 , wherein the immune response is bactericidal against a N. meningitidis serogroup B subfamily B strain that is heterologous to N. meningitidis strain CDC1573.

5 . The method according to claim 1 , wherein the immune response is bactericidal against at least one N. meningitidis serogroup B strain that expresses fHBP selected from: A22 fHBP; A56 fHBP; B24 fHBP; and B44 fHBP.

6 . The method according to claim 1 , wherein the immune response is bactericidal against at least one N. meningitidis serogroup B strain that expresses fHBP selected from: A29 fHBP; A06 fHBP; A07 fHBP; A12 fHBP; A15 fHBP; A19 fHBP; B03 fHBP; B09 fHBP, B15 fHBP, and B16 fHBP.

7 . The method according to claim 1 , wherein the N. meningitidis rLP2086 composition further comprises polysorbate-80.

8 . The method according to claim 7 , wherein the N. meningitidis rLP2086 composition further comprises aluminum.

9 . The method according to claim 8 , wherein the N. meningitidis rLP2086 composition further comprises histidine buffer.

10 . The method according to claim 9 , wherein the N. meningitidis rLP2086 composition further comprises sodium chloride.

11 . The method according to claim 1 , wherein the N. meningitidis rLP2086 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.

12 . The method according to claim 1 , wherein the N. meningitidis rLP2086 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.

13 . The method according to claim 1 , wherein the effective amount of the N. meningitidis rLP2086 composition comprises one dose.

14 . The method according to claim 1 , wherein the effective amount of the N. meningitidis rLP2086 composition comprises two doses.

15 . The method according to claim 14 , wherein the effective amount of the N. meningitidis rLP2086 composition further comprises a booster dose.

16 . The method according to claim 1 , wherein the effective amount of the N. meningitidis rLP2086 composition comprises at most three doses.

Assignments (1)
ASSIGNEE ADDRESS CORRECTION Recorded Mar 20, 2023
From: PFIZER INC.
To: PFIZER INC.
Reel/Frame 063119/0087 →