IMMUNOGENIC COMPOSITION

• US 20170065714A1
• Filed: 09/14/2016
• Published: 03/09/2017
• Est. Priority Date: 06/27/2005
• Status: Active Grant

• Current Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Original Assignee: Glaxosmithkline Biologicals SA (GlaxoSmithKline PLC)
• Inventors: Biemans, Ralph Leon, Boutriau, Dominique, Capiau, Carine, Denoel, Philippe, Duvivier, Pierre, Poolman, Jan
• Granted Patent: US 10,245,317 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/545 characterised by the dose, timing or administration schedule
• CPC Class Codes: A61K 2039/55 characterised by the host/recipient, e.g. newborn with maternal antibodies
• CPC Class Codes: A61K 2039/575 humoral response
• CPC Class Codes: A61K 2039/6037 Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
• CPC Class Codes: A61K 2039/62 characterised by the link between antigen and carrier
• CPC Class Codes: A61K 2039/627 characterised by the linker
• CPC Class Codes: A61K 2039/70 Multivalent vaccine
• CPC Class Codes: A61K 39/0017 Combination vaccines based on whole cell diphtheria-tetanus-pertussis
• CPC Class Codes: A61K 39/0018 Combination vaccines based on acellular diphtheria-tetanus-pertussis
• CPC Class Codes: A61K 39/05 Actinobacteria, e.g. Actinomyces, Streptomyces, Nocardia, Bifidobacterium, Gardnerella, Corynebacterium; Propionibacterium Mycobacterium A61K39/04
• CPC Class Codes: A61K 39/08 Clostridium, e.g. Clostridium tetani
• CPC Class Codes: A61K 39/092 Streptococcus
• CPC Class Codes: A61K 39/095 Neisseria
• CPC Class Codes: A61K 39/099 Bordetella
• CPC Class Codes: A61K 39/102 Pasteurellales, e.g. Actinobacillus, Pasteurella; Haemophilus
• CPC Class Codes: A61K 39/116 Polyvalent bacterial antigens
• CPC Class Codes: A61K 39/12 Viral antigens
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 39/292 Serum hepatitis virus, hepatitis B virus, e.g. Australia antigen
• CPC Class Codes: A61K 39/385 Haptens or antigens, bound to carriers
• CPC Class Codes: A61P 11/04 : for throat disorders
• CPC Class Codes: A61P 11/14 : Antitussive agents
• CPC Class Codes: A61P 31/00 : Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 31/20 : for DNA viruses
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 37/04 : Immunostimulants
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07H 3/00 : Compounds containing only hydrogen atoms and saccharide radicals having only carbon, hydrogen, and oxygen atoms preparation by hydrolysis of di-or polysaccharides C13; separation or purification of sucrose, glucose, fructose, lactose or maltose C13
• CPC Class Codes: C12N 2730/10134 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16234 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 2760/16271 : Demonstrated in vivo effect
• CPC Class Codes: C12N 2770/32634 : Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 : Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The present application discloses an immunogenic composition comprising at least 2 different N. meningitidis capsular saccharides, wherein one or more is/are selected from a first group consisting of MenA, MenC, MenY and MenW which is/are conjugated through a linker to a carrier protein(s), and one or more different saccharides is/are selected from a second group consisting of MenA, MenC, MenY and MenW which is/are directly conjugated to a carrier protein(s).

Claims

1-106. -106. (canceled)

107. An immunogenic composition, comprising:

(a) a Neisseria meningitidis (N. meningitides) serogroup A capsular saccharide conjugated to an adipic acid dihydrazide (ADH) linker, wherein the linker is conjugated to tetanus toxoid carrier protein;

(b) a N. meningitidis serogroup C capsular saccharide conjugated to an adipic acid dihydrazide (ADH), wherein the linker is conjugated to tetanus toxoid carrier protein;

(c) a N. meningitidis serogroup W capsular saccharide directly conjugated to tetanus toxoid carrier protein in the absence of a linker; and

(d) a N. meningitidis serogroup Y capsular saccharide directly conjugated to tetanus toxoid carrier protein in the absence of a linker;

wherein the ratio of Men A saccharide to carrier protein is between 1;

2 to 1;

5 (w/w); and

wherein the ratio of MenC saccharide to carrier protein is between 1;

2 to 1;

5 (w/w).

108. The immunogenic composition of claim 107, wherein the ratio of Men W and/or Y saccharide to carrier protein is between 1:

0.5 and 1;

2 (w/w).

109. The immunogenic composition of claim 107, wherein the composition does not include an adjuvant.

110. The immunogenic composition of claim 107, wherein the composition does not include an aluminum salt adjuvant.

111. The immunogenic composition of claim 107, further comprising sucrose.

112. The immunogenic composition of claim 107, further comprising a N. meningitidis serogroup B outer membrane vesicle preparation or capsular saccharide.

113. The immunogenic composition of claim 107, further comprising Haemophilus influenza (H. influenzae) b capsular saccharide conjugated to a carrier protein, the carrier protein selected from the group consisting of tetanus toxoid, diphtheria toxoid, cross reactive material 197, fragment C of tetanus toxoid and protein D, wherein the H. influenzae b conjugate is present in a lower dose than the dose of any other bacterial saccharide conjugate.

114. The immunogenic composition of claim 107, wherein the H. influenzae b capsular saccharide (Hib) is conjugated to tetanus toxoid.

115. A pharmaceutical composition, comprising the immunogenic composition of claim 107 and a pharmaceutically acceptable excipient.

116. A process for making a vaccine, comprising the step of mixing the immunogenic composition of claim 107 with a pharmaceutically acceptable excipient.

117. A method of immunizing a human host against disease caused by Neisseria meningitidis infection, comprising administering to the host an immunoprotective dose of the immunogenic composition of claim 107.

118. A method of treating or preventing disease caused by Neisseria meningitidis infection, comprising administering to a human patient in need thereof the immunogenic composition of claim 107.