Neisseria meningitidis compositions and methods thereof

Patent metadata

Field	Value
Publication number	US-10813989-B2
Application number	US-201916704701-A
Country	US
Kind code	B2
Filing date	Dec 5, 2019
Priority date	Jan 31, 2017
Publication date	Oct 27, 2020
Grant date	Oct 27, 2020

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 kit comprising (a) a first composition comprising aluminum, a lipidated MenB rLP2086 subfamily A polypeptide set forth as SEQ ID NO: 1 and a lipidated MenB rLP2086 subfamily B polypeptide set forth as SEQ ID NO: 2; and (b) a second composition comprising a Neisseria meningitidis serogroup A (MenA) capsular saccharide conjugated to tetanus toxoid carrier protein (TT); a Neisseria meningitidis serogroup C (MenC) capsular saccharide conjugated to tetanus toxoid carrier protein (TT); a Neisseria meningitidis serogroup W135 (MenW) capsular saccharide conjugated to tetanus toxoid carrier protein (TT); and a Neisseria meningitidis serogroup Y (MenY) capsular saccharide conjugated to tetanus toxoid carrier protein (TT).

2. The kit according to claim 1 , wherein the first composition is a liquid composition.

3. The kit according to claim 1 , wherein the second composition is a lyophilized composition.

4. The kit according to claim 3 , wherein the lyophilized composition does not comprise polysorbate 80.

5. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup A (MenA) capsular saccharide is conjugated to an adipic acid dihydrazide (ADH) linker by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, and wherein the linker is conjugated to tetanus toxoid carrier protein (TT) by carbodiimide chemistry (MenA AH -TT conjugate).

6. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup C (MenC) capsular saccharide is conjugated to an ADH linker by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, wherein the linker is conjugated to tetanus toxoid carrier protein (TT) by carbodiimide chemistry (MenC AH -TT conjugate).

7. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup W 135 (MenW) capsular saccharide directly conjugated to tetanus toxoid carrier protein (TT) by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, in the absence of a linker (MenW-TT conjugate).

8. The kit according to claim 1 , wherein the Neisseria meningitidis serogroup Y (MenY) capsular saccharide directly conjugated to tetanus toxoid carrier protein (TT) by 1-cyano-4-dimethylamino pyridinium tetrafluoroborate chemistry, in the absence of a linker (MenY-TT conjugate).

9. The kit according to claim 1 , wherein the first composition further comprises sodium chloride.

10. The kit according to claim 1 , wherein the first composition further comprises L-Histidine.

11. The kit according to claim 1 , wherein the first composition further comprises polysorbate 80.

12. The kit according to claim 11 , wherein the molar ratio of the polysorbate-80 to rLP2086 polypeptide is between 1.4 to 4.2.

13. The kit according to claim 1 , wherein the first composition comprises aluminum phosphate.

14. The kit according to claim 1 , wherein the first composition does not further comprise Tris-HCl.

15. The kit according to claim 1 , wherein the first composition does not further comprise sucrose.

16. The kit according to claim 1 , wherein the second composition further comprises sodium chloride.

17. The kit according to claim 1 , wherein the second composition does not comprise polysorbate-80.

18. The kit according to claim 1 , wherein the second composition comprises at least 0.010 mg polysorbate-80 and at most 0.018 mg polysorbate-80.

19. The kit according to claim 1 , wherein the second composition comprises at least 0.010 mg polysorbate-80 and at most 0.02 mg polysorbate-80.

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