Combination vaccines with serogroup B meningococcus and D/T/P

Patent metadata

Field	Value
Publication number	US-9526776-B2
Application number	US-201314420238-A
Country	US
Kind code	B2
Filing date	Sep 6, 2013
Priority date	Sep 6, 2012
Publication date	Dec 27, 2016
Grant date	Dec 27, 2016

Abstract

Serogroup B meningococcus antigens can successfully be combined with diphtheria, tetanus and pertussis toxoids (“DTP”) to provide effective combination vaccines for protecting against multiple pathogens. These combinations are effective with a range of different adjuvants, and with both pediatric-type and booster-type DTP ratios. The adjuvant can improve the immune response which the composition elicits; alternatively, by including an adjuvant it is possible for the compositions to have a relatively lower amount of antigen while nevertheless having immunogenicity which is comparable to unadjuvanted combination vaccines.

First claim

The invention claimed is:

1. An immunogenic composition, comprising: (a) a recombinant or purified serogroup B meningococcus immunogen, wherein the serogroup B meningococcus immunogen comprises a meningococcal factor H binding protein (fHbp) or a polypeptide having at least 85% sequence identity to SEQ ID NO: 4 or SEQ ID NO: 19; (b) a diphtheria toxoid, a tetanus toxoid, and a pertussis toxoid, wherein the tetanus toxoid is present in an excess relative to diphtheria toxoid as measured in Lf units; and (c) an adjuvant, wherein the adjuvant comprises an oil-in-water emulsion.

2. The composition of claim 1 , further comprising in component (a) a Neisserial Heparin Binding Antigen (NHBA) protein or a polypeptide having at least 85% sequence identity to SEQ ID NO: 5 and a Neisserial adhesin A (NadA) protein or a polypeptide having at least 85% sequence identity to SEQ ID NO: 6.

3. The composition of claim 1 , wherein the fHbp protein or the polypeptide is located in a meningococcal vesicle.

4. A method of raising an immune response in a mammalian subject, comprising the step of administering an effective amount of the composition of claim 1 to the subject.

5. An immunogenic composition, comprising: (a) a recombinant or purified serogroup B meningococcus immunogen, wherein the serogroup B meningococcus immunogen comprises a meningococcal fHbp protein or a polypeptide having at least 85% sequence identity to SEQ ID NO: 4 or SEQ ID NO: 19; (b) a diphtheria toxoid, a tetanus toxoid, and a pertussis toxoid, wherein the tetanus toxoid is present in an excess relative to diphtheria toxoid as measured in Lf units; and (c) an adjuvant, wherein the adjuvant comprises an aluminium salt and a TLR agonist wherein the TLR agonist is adsorbed to the aluminium salt.

6. The composition of claim 5 , wherein the adjuvant further comprises an oil-in-water emulsion.

7. The composition of claim 5 , further comprising in component (a) a NHBA protein or a polypeptide having at least 85% sequence identity to SEQ ID NO: 5 and a NadA protein or a polypeptide having at least 85% sequence identity to SEQ ID NO: 6.

8. The composition of claim 5 , wherein the fHbp protein or the polypeptide having at least 85% sequence identity to SEQ ID NO: 4 or SEQ ID NO: 19 is located in a meningococcal vesicle.

9. The composition of claim 5 , wherein the TLR agonist is a TLR4 agonist, a TLR7 agonist, or a combination thereof.

10. The composition of claim 9 , wherein the TLR agonist is a TLR7 agonist.

11. The composition of claim 10 , wherein the TLR7 agonist is 3-(5-amino-2-(2-methyl-4-(2-(2-(2-phosphonoethoxy)ethoxy)ethoxy)phenethyl)benzo[f]-[1,7]naphthyridin-8-yl)propanoic acid, or a salt thereof.

Assignees

• Glaxosmithkline Biologicals Sa

Inventors

• Baudner Barbara
• O'Hagan Derek
• Singh Manmohan
• Bufali Simone

Classifications

• A61K39/39

  characterised by the immunostimulating additives, e.g. chemical adjuvants · CPC title

• A61K2039/6037

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

• A61K39/095 Primary

  Neisseria · CPC title

• A61K2039/55572

  Lipopolysaccharides; Lipid A; Monophosphoryl lipid A · CPC title

• A61P37/04

  Immunostimulants · CPC title