Neisseria meningitidis compositions and methods thereof

Patent metadata

Field	Value
Publication number	US-11730800-B2
Application number	US-202017024618-A
Country	US
Kind code	B2
Filing date	Sep 17, 2020
Priority date	Jan 31, 2017
Publication date	Aug 22, 2023
Grant date	Aug 22, 2023

Abstract

In one aspect, the invention relates to a composition including a factor H binding protein (fHBP) and a Neisseria meningitidis non-serogroup B capsular polysaccharide. The invention further relates to uses of a composition that includes fHBP, such as, for example, uses to elicit an immune response against N. meningitidis serogroup B strains and non-serogroup B strains. The compositions and methods described herein are directed to administration in humans, including adults, adolescents, toddlers, and infants.

First claim

What is claimed is:

1. A method of inducing an immune response against a Neisseria meningitidis serogroup A strain expressing B16 factor H binding protein in a human comprising mixing (a) a composition comprising (i) a first lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 1; (ii) a second lipidated polypeptide comprising the amino acid sequence set forth in SEQ ID NO: 2; (iii) a Neisseria meningitidis serogroup A (MenA) capsular saccharide conjugated to an adipic acid dihydrazide (ADH) linker, wherein the linker is conjugated to tetanus toxoid (TT); (iv) a Neisseria meningitidis serogroup C (MenC) capsular saccharide conjugated to an ADH linker, wherein the linker is conjugated to tetanus toxoid (TT); (v) a Neisseria meningitidis serogroup W135 (MenW) capsular saccharide conjugated to tetanus toxoid (TT) (MenW-TT conjugate); and (vi) a Neisseria meningitidis serogroup Y (MenY) capsular saccharide directly conjugated to tetanus toxoid (TT) (MenY-TT conjugate); and (b) administering an effective amount of the composition to the human, wherein the composition comprises about 5 μg of the MenA capsular saccharide conjugated to about 7.5 μg of the TT; about 5 μg of the MenC capsular saccharide conjugated to about 7.5 μg of the TT; about 5 μg of the MenW capsular saccharide conjugated to about 3.75 μg of the TT; and about 5 μg of the MenY capsular saccharide conjugated to about 3.25 μg of the TT per dose; and further comprises aluminum.

2. The method according to claim 1 , wherein at least 90% of the total composition of the first polypeptide is bound to the aluminum in the composition.

3. The method according to claim 1 , wherein at least 90% of the total composition of the second polypeptide is bound to the aluminum in the composition.

4. The method according to claim 1 , wherein the composition further comprises polysorbate-80.

5. The method according to claim 1 , wherein the composition further comprises sucrose.

6. The method according to claim 1 , wherein the composition further comprises histidine.

7. The method according to claim 1 , wherein the composition comprises about 120 μg/ml of the first polypeptide; about 120 μg/ml of the second polypeptide; about 0.5 mg/ml of the aluminum as aluminum phosphate; about 0.02 mg polysorbate-80; about 10 mM histidine; and about 150 mM sodium chloride.

8. The method of claim 1 , wherein the composition comprises about 60 μg of the first polypeptide; about 60 μg of the second polypeptide; about 5 μg of the MenA capsular saccharide conjugated to about 7.5 μg of the TT; about 5 μg of the MenC capsular saccharide conjugated to about 7.5 μg of the TT; about 5 μg of the MenW capsular saccharide conjugated to about 3.75 μg of the TT; and about 5 μg of the MenY capsular saccharide conjugated to about 3.25 μg of the TT per dose; about 97 μg of Tris-HCl, pH 6.8±0.3; 4.69-4.71 mg of sodium chloride; about 28 mg of sucrose; about 0.78 mg of L-Histidine; about 0.02 mg polysorbate-80; about 0.25 mg of the aluminum; and further comprising 0.5 mL water, per dose.

9. The method according to claim 1 , wherein the first polypeptide consists of the amino acid sequence set forth in SEQ ID NO: 1.

10. The method according to claim 1 , wherein the second polypeptide consists of the amino acid sequence set forth in SEQ ID NO: 2.

11. The method according to claim 1 , wherein the composition does not comprise a hybrid protein.

12. The method according to claim 1 , wherein the composition does not comprise a fusion protein.

13. The method according to claim 1 , wherein the composition is not lyophilized.

14. The method according to claim 1 , wherein the composition does not comprise formaldehyde.

15. The method according to claim 1 , wherein the composition does not comprise diphtheria toxoid or CRM.

16. The method according to claim 1 , wherein the human is aged less than 12 months.

17. The method according to claim 1 , wherein the human is aged 12 months to 18 months.

18. The method according to claim 1 , wherein the human is aged 18 months to 24 months.

19. The method according to claim 1 , wherein the human is aged 24 months to 10 years.

20. The method according to claim 1 , wherein the human is aged at least 10 years.

21. The method according to claim 1 , wherein the human is aged 10 to 25 years.

Assignees

• Pfizer

Inventors

• Jansen Kathrin Ute
• Anderson Annaliesa Sybil
• Absalon Judith
• Aste-Amezaga Jose Miguel
• Beeslaar Johannes Frederik
• Cooper David
• Farley John Erwin
• Fletcher Leah Diane
• Harris Shannon Lea
• Jones Thomas Richard
• Kanevsky Isis
• Khandke Lakshmi
• Liberator Paul
• Perez John Lance
• Phelan Lynn Marie
• Zlotnick Gary Warren

Classifications

• A61K2039/6037

  Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT] · CPC title

• A61P31/04

  Antibacterial agents · CPC title

• A61K47/22

  Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones · CPC title

• A61K47/02

  Inorganic compounds · CPC title

• A61K47/26

  Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin · CPC title