WO2011074006A4

WO2011074006A4 - Vaccine composition

Info

Publication number: WO2011074006A4
Application number: PCT/IN2010/000814
Authority: WO
Inventors: Jadhav Suresh Sakharam; Gairola Sunil Jagdishprasad; Gautam Manish Maheshkumar
Original assignee: Serum Institute Of India Ltd.
Priority date: 2009-12-16
Filing date: 2010-12-16
Publication date: 2012-01-05
Also published as: BR112012014689B1; WO2011074006A2; CN102655879A; WO2011074006A3; BR112012014689A2; CN102655879B

Abstract

The instant invention provides cost effective and immunogenic IPV formulations.The said formulations contain an adjuvant that can enable 5 to 10 fold dose reduction for inactivated polio virus vaccines.

Claims

AMENDED CLAIMS received by the International Bureau on 17 November 201 1 (17.1 1.201 1 ) We claim:

1. An immunogenic composition for inducing improved humoral response against polio antigen comprising of a) a low amount of polio virus antigen or antigenic preparation and b) an oil-in-water emulsion adjuvant.

2. An immunogenic composition according to claim 1, wherein the effective dose of inactivated polio virus D antigen is reduced by atleast 5 fold.

3. An immunogenic composition according to claim 1, wherein the effective dose of inactivated polio virus D antigen is reduced preferably by 10 fold.

4 . The immunogenic composition of claim 1 , wherein said oil-in-water emulsion comprises a metabolisable oil .

5. The immunogenic composition of claim 4, wherein said metabolisable oil is squalene.

6. The immunogenic composition of claim 4 or claim 5, wherein said metabolisable oil is present at an amount of 0.5-10, 0.5-9, 1-10, 2-10, 4-8, 1-2, 2-3, 4.5-5.5, 5-6 or 9- 10 or 10-11 mg, per human dose.

7. The immunogenic composition of claim 1 , wherein said emulsifying agent is a non-ionic surfactant.

8. The immunogenic composition of claims 7, wherein said emulsifying agent is a polyoxyethylene sorbitan monooleate or a sorbitan trioleate or a mixture of both.

9. The immunogenic composition of claim 7, wherein said polyoxyethylene sorbitan monooleate is selected from the group comprising: polysorbate 80 or Tween® 80, and sorbitan trioleate is Span85.

10. The immunogenic composition of any one of claims 1 to 9, wherein said emulsifying agent is present at an amount of 0.1-5, 0.2-5, 0.3-5, 0.4-5, 0.4-1.2, 0.5-4, 1-2, 2-3 or 4-5.5 mg per human dose.

11. The immunogenic composition of any one of claims 1 to 10, wherein said adjuvant further comprises a tocol.

12. The immunogenic composition of claim 11 , wherein said tocol is alpha-tocopherol.

13. The immunogenic composition of claim or claim 12, wherein said tocol is present at an amount of 0.5-12, 1-1 1 , 2-10, 4-9, 5-6, 5-7, 2.5-3.5, 1-2, 1-3 or 10-11 or 11-12 mg per human dose.

14. The immunogenic composition of claims 1-13, wherein the adjuvant is selected from group consisting of i) 10-1 lmg metabolisable oil, 4.5-5.5 mg emulsifying agent , and when present 11.5-12.5 mg tocol per human dose;

ii) 10.5-11 mg metabolisable oil, 4.6-5.2 mg emulsifying agent, and when present 11.6-12.2 mg tocol per human dose

15. The immunogenic composition of claims 1 to 14 wherein said composition is a monovalent composition comprising a polio virus D antigen or antigenic preparation from atleast one inactivated polio virus type selected from a group consisiting of polio virus type 1, type 2 and type 3.

16. The immunogenic composition of claims 1 to 14 wherein said composition is a multivalent composition comprising a polio virus D antigen or antigenic preparation from atleast 2 or atleast 3 inactivated polio virus types.

17. An IPV dose reduced composition according to claim 16, wherein the dose for multivalent composition is selected from a group consisting of i) D antigens as 8 Units of inactivated poliovirus type 1, 1.6 units of inactivated poliovirus type 2 and 6.4 units of inactivated poliovirus type 3 . ii) D antigens as 6.6 Units of inactivated poliovirus type 1, 1.3 units of inactivated poliovirus type 2 and 5.3 units of inactivated poliovirus type 3 . iii) D antigens as 5.7 Units of inactivated poliovirus type 1, 1.1 units of inactivated poliovirus type 2 and 4.5 units of inactivated poliovirus type 3 . iv) D antigens as 5 Units of inactivated poliovirus type 1, 1 units of inactivated poliovirus type 2 and 4 units of inactivated poliovirus type 3 . v) D antigens as 4.4 Units of inactivated poliovirus type 1, 0.88 units of inactivated poliovirus type 2 and 3.5 units of inactivated poliovirus type 3 . vi) D antigens as 4 Units of inactivated poliovirus type 1, 0.8 units of inactivated poliovirus type 2 and 3.2 units of inactivated poliovirus type 3 .

18. A vaccine kit comprising a polio virus D antigen component or antigenic preparation as defined in any of the preceeding claims ,that comprises of (a) a low amount, as herein defined, of polio virus antigen or antigenic preparation thereof and (b) an oil-in- water emulsion adjuvant.

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19. The immunogenic composition according to any preceding claim wherein said human dose is selected from: 0.5 ml or less, between 0.5 and 1.5 ml, between 0.2 and 1.2 ml, between 0.2 and 0.7 ml and less than or exactly 0.25, or 0.5, or 0.7, or 1 ml.

20. The immunogenic composition according to any preceeding claim, wherein the polio antigen and the oil-in-water emulsion adjuvant are contained in the same container.

21. The immunogenic composition according to any preceeding claim, wherein the polio antigen and the oil-in-water emulsion adjuvant are contained in separate containers or vials or units and admixed shortly before or upon administration into the subject.

22. An immunogenic composition of any preceding claim characterized in that the composition is single dose or multidose.

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STATEMENT UNDER ARTICLE 19 (1)

The applicant herewith submits that the cited documents do not disclose the invention of the instant international application.

• Jira et al(US2003/0092145) does not teach specifically "dose reduction" for polio antigens, Jira et al only teaches dose ranges for viral vaccines in general.

• Novartis (US2009/0208526) does not teach specifically "dose reduction" for polio antigens, Novartis only teaches dose reduced Hib conjugate.

• Novartis (US 2009/0130146) does not teach "dose reduction" and only discusses use of MF-59 as adjuvant.

The applicant has revised the claims and humbly submits that :

• The ISA has not considered IPV dose reduction aspect (part of claims 8-23) while carrying out prior art search. Thus in the revised claim set, we have inserted claim 22 & 23 after claim 1 , please refer attachment.

• According to us it is crucial to note that in combination vaccines it has been reported that aluminum based adjuvant enable 3 to 4 fold reduction in IPV(Inactivated Polio Virus Vaccine) dose, please refer Eighth WHO UNICEF consultation with OPV/IPV manufacturers and NRAs 30th Oct 2009 , Geneva, WHO/HQ. The 3-4 fold reduction is predicted to be insufficient for stretching global vaccine supplies and significant reduction in cost of manufacture.

• Thus the technical problem solved by our invention is providing dose reduction of more than 5 fold (preferably 10 fold) specifically for IPV.