Title:
VACCINE AGAINST STREPTOCOCCUS PNEUMONIAE
Document Type and Number:
WIPO Patent Application WO/2000/056359
Kind Code:
A2
Abstract:
The present invention relates to the field of bacterial polysaccharide antigen vaccines. In particular, the present invention relates to vaccines comprising a pneumococcal polysaccharide antigen, typically a pneumococcal polysaccharide conjugate antigen, formulated with a protein antigen form $i(Streptococcus pneumoniae), and optionally a Th1-inducing adjuvant.
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Inventors:
CAPIAU CARINE (BE)
DESCHAMPS MARGUERITE (BE)
DESMONS PIERRE MICHEL (BE)
LAFERRIERE CRAIG ANTONY JOSEPH (BE)
POOLMAN JAN (BE)
PRIEELS JEAN-PAUL (BE)
DESCHAMPS MARGUERITE (BE)
DESMONS PIERRE MICHEL (BE)
LAFERRIERE CRAIG ANTONY JOSEPH (BE)
POOLMAN JAN (BE)
PRIEELS JEAN-PAUL (BE)
Application Number:
PCT/EP2000/002467
Publication Date:
September 28, 2000
Filing Date:
March 17, 2000
Export Citation:
Assignee:
SMITHKLINE BEECHAM BIOLOG (BE)
CAPIAU CARINE (BE)
DESCHAMPS MARGUERITE (BE)
DESMONS PIERRE MICHEL (BE)
LAFERRIERE CRAIG ANTONY JOSEPH (BE)
POOLMAN JAN (BE)
PRIEELS JEAN PAUL (BE)
CAPIAU CARINE (BE)
DESCHAMPS MARGUERITE (BE)
DESMONS PIERRE MICHEL (BE)
LAFERRIERE CRAIG ANTONY JOSEPH (BE)
POOLMAN JAN (BE)
PRIEELS JEAN PAUL (BE)
International Classes:
A61K39/09; A61K35/74; A61K39/005; A61K39/02; A61K39/04; A61K39/05; A61K39/085; A61K39/095; A61K39/102; A61K39/112; A61K39/116; A61K39/155; A61K39/385; A61K39/39; A61P11/00; A61P27/06; A61P31/04; A61P37/04; C07K14/285; C12N15/09; A61K39/00; A61K; A61P; (IPC1-7): A61K39/09; A61K39/385; A61K39/39; A61P31/04
Domestic Patent References:
| WO1990006951A1 | 1990-06-28 | |||
| WO1996033739A1 | 1996-10-31 | |||
| WO1995017209A1 | 1995-06-29 |
Other References:
LEE C J ET AL: "Immunologic epitope, gene, and immunity involved in pneumococcal glycoconjugate." CRITICAL REVIEWS IN MICROBIOLOGY, vol. 23, no. 2, 1997, pages 121-141, XP000946772
BRILES DAVID E ET AL: "Pneumococcal diversity: Considerations for new vaccine strategies with emphasis on pneumococcal surface protein A (PspA)." CLINICAL MICROBIOLOGY REVIEWS, vol. 11, no. 4, October 1998 (1998-10), pages 645-657, XP000946754 ISSN: 0893-8512
ALEXANDER JANET E ET AL: "Immunization of Mice with Pneumolysin Toxoid Confers a Significant Degree of Protection against At Least Nine Serotypes of Streptococcus pneumoniae." INFECTION AND IMMUNITY, vol. 62, no. 12, 1994, pages 5683-5688, XP002149967 ISSN: 0019-9567
MICHON F ET AL: "Multivalent pneumococal capsular polysaccharide conjugate vaccines employing genetically detoxified pneumolysin as a carrier protein" VACCINE,GB,BUTTERWORTH SCIENTIFIC. GUILDFORD, vol. 16, no. 18, 1998, pages 1732-1741, XP002089380 ISSN: 0264-410X
DE VELASCO E ALONSO ET AL: "Synthetic peptides representing T-cell epitopes act as carriers in pneumococcal polysaccharide conjugate vaccines." INFECTION AND IMMUNITY, vol. 63, no. 3, 1995, pages 961-968, XP002149966 ISSN: 0019-9567
BRILES DAVID E ET AL: "Pneumococcal diversity: Considerations for new vaccine strategies with emphasis on pneumococcal surface protein A (PspA)." CLINICAL MICROBIOLOGY REVIEWS, vol. 11, no. 4, October 1998 (1998-10), pages 645-657, XP000946754 ISSN: 0893-8512
ALEXANDER JANET E ET AL: "Immunization of Mice with Pneumolysin Toxoid Confers a Significant Degree of Protection against At Least Nine Serotypes of Streptococcus pneumoniae." INFECTION AND IMMUNITY, vol. 62, no. 12, 1994, pages 5683-5688, XP002149967 ISSN: 0019-9567
MICHON F ET AL: "Multivalent pneumococal capsular polysaccharide conjugate vaccines employing genetically detoxified pneumolysin as a carrier protein" VACCINE,GB,BUTTERWORTH SCIENTIFIC. GUILDFORD, vol. 16, no. 18, 1998, pages 1732-1741, XP002089380 ISSN: 0264-410X
DE VELASCO E ALONSO ET AL: "Synthetic peptides representing T-cell epitopes act as carriers in pneumococcal polysaccharide conjugate vaccines." INFECTION AND IMMUNITY, vol. 63, no. 3, 1995, pages 961-968, XP002149966 ISSN: 0019-9567
Attorney, Agent or Firm:
Giddings, Peter John (SmithKline Beecham Corporate Intellectual
Property Two New Horizons Court Brentford
Middlesex TW8 9EP, GB)
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Claims:
Claims: <BR> <BR>
<BR> <BR>
| 1. | An immunogenic composition comprising at least one Streptococcus pneumoniae polysaccharide antigen and at least one Streptococcus pneumoniae protein antigen or immunologically functional equivalent thereof. |
| 2. | The immunogenic composition of claim 1, wherein the protein antigen is an outer surface protein or a secreted protein of Streptococcus pneumoniae or immunologically functional equivalents thereof. |
| 3. | The immunogenic composition of claims 1 or 2, wherein the protein antigen is a toxin, adhesin or lipoprotein of Streptococcus pneumoniae or immunologically functional equivalents thereof. |
| 4. | The immunogenic composition of claims 13, wherein the protein antigen or immunologically functional equivalent thereof is selected from the group: pneumolysin, PspA or transmembrane deletion variants thereof, PspC or transmembrane deletion variants thereof, PsaA or transmembrane deletion variants thereof, glyceraldehyde3phosphate dehydrogenase, and CbpA or transmembrane deletion variants thereof. |
| 5. | The immunogenic composition of claims 14, wherein the polysaccharide antigen is presented in the form of a polysaccharideprotein carrier conjugate. |
| 6. | The immunogenic composition of claim 5, wherein the carrier protein is selected from the group consisting of Diphtheria toxoid, Tetanus toxoid, CRM197, Keyhole Limpet Haemocyanin (KLH), protein derivative of Tuberculin (PPD), and protein D from H. influenzae. |
| 7. | An immunogenic composition as claimed in any of claims 1 to 6 wherein the vaccine comprises at least four pneumococcal polysaccharide antigens from different serotypes. |
| 8. | An immunogenic composition as claimed herein additionally comprising an adjuvant. |
| 9. | An immunogenic composition as claimed in claim 8, wherein the adjuvant comprises an aluminium salt. |
| 10. | An immunogenic composition as claimed in claim 8, wherein the adjuvant is a preferential inducer of a TH1 response. |
| 11. | An immunogenic composition as claimed in claim 10, wherein the adjuvant comprises at least one of the following: 3DMPL, a saponin immunostimulant, or an immunostimulatory CpG oligonucleotide. |
| 12. | An immunogenic composition as claimed in claim 11, wherein the adjuvant comprises a carrier selected from the group comprising: an oil in water emulsion, liposomes, and an aluminium salt. |
| 13. | An immunogenic composition composition as claimed herein for use as a medicament. |
| 14. | A vaccine comprising the immunogenic composition of claims 112. |
| 15. | A method of preventing or ameliorating Streptoccocus pneumoniae infection in a patient over 55 years, comprising administering an effective amount of a vaccine comprising a Streptococcus pneumoniae polysaccharide and at least one Streptococcus pneumoniae protein, and optionally a TH1 inducing adjuvant. |
| 16. | Use of a pneumococcal polysaccharide antigen in combination with a Streptoccocus pneumoniae protein antigen, and optionally a TH1 inducing adjuvant, in the manufacture of a medicament for the prevention of pneumonia in patients over 55 years. |
| 17. | A method of making an immunogenic composition as claimed herein, comprising the steps of : selecting one or more pneumococcal polysaccharide antigen (s); selecting one or more pneumococcal protein antigen (s); and mixing said polysaccharide and protein antigens with a suitable excipient. |
| 18. | A method of preventing or ameliorating Otitis media in Infants, comprising administering a safe and effective amount of a vaccine comprising a Streptococcus pneumoniae polysaccharide antigen and a Streptococcus pneumoniae protein antigen optionally with a TH1 adjuvant, to said Infant. |
Description:
INTERNATIONAL SEARCH REPORT Interr nal Application rao !ntefrna)App)!cat!onNo PCT/EP00/02467 C.(Continuatlon)DOCUMENTSCONSIDEREDTOBERELEVANT Categoryo Citationofdocument,withindication,whereappropriate,oftherele
vantpassagesRelevanttoclaimNo. XBRILESDAVIDEETAL:"Pneumococcal1-7, diversity:Considerationsfornewvaccine13-18 strategieswithemphasisonpneumococcal surfaceproteinA(PspA)." CLINICALMICROBIOLOGYREVIEWS, vol.11,no.4,October1998(1998-10), pages645-657,XP000946754 ISSN:0893-8512 Ythewholedocumentespeciallypage6468-12 column1line35-page646column2line 9;page653column1line27-46 YWO9633739A(SMITHKLINEBEECHAMBIOLOG8-12 ;GARCONNATHALIEMARIEJOSEPHE(BE);FRI) 31October1996(1996-10-31) citedintheapplication page1,line1-page3,line21 claims1,5,8-10,12 XALEXANDERJANETEETAL:"Immunizationof1-5, MicewithPneumolysinToxoidConfersa13-18 SignificantDegreeofProtectionagainst AtLeastNineSerotypesofStreptococcus pneumoniae." INFECTIONANDIMMUNITY, vol.62,no.12,1994,pages5683-5688, XP002149967 ISSN:0019-9567 page5683,column1,line26-column2, line8 page5687,column1,line51-line58 AMICHONFETAL:"Multivalentpneumococal1-5,7-9, capsularpolysaccharideconjugatevaccines13-18 employinggeneticallydetoxified pneumolysinasacarrierprotein" VACCINE,GB,BUTTERWORTHSCIENTIFIC. GUILDFORD, vol.16,no.18,1998,pages1732-1741, XP002089380 ISSN:0264-410X thewholedocument ADEVELASCOEALONSOETAL:"Synthetic1-5, peptidesrepresentingT-cellepitopesact8-11, ascarriersinpneumococcalpolysaccharide13-18 conjugatevaccines." INFECTIONANDIMMUNITY, vol.63,no.3,1995,pages961-968, XP002149966 ISSN:0019-9567 thewholedocument 1 1 INTERNATIONALSEARCHREPORT InterrnalApplicationNo PCT/EP00/02467 C.(Continuation)DOCUMENTSCONSIDEREDTOBERELEVANT Category ° Citabonofdocument,withindication,whereappropriate,oftherelev
antpassagesRelevanttoclaimNo. AWO9517209A(SMITHKLINEBEECHAMBIOLOG10-12 ;MOMINPATRICIAMARIE(BE);GARCONNATHA) 29June1995(1995-06-29) citedintheapplication page4,line26-page5,line16 claims1-5,8-10,12,13 1 INTERNATIONALSEARCHREPORT Interr nal ApplicationNo Information on patent tamily members PCT/EP00/02467 PatentdocumentPublication Patent citedinsearchreportdate member(s)date WO9006951A28-06-1990AU 626961 B 13-08-1992 AU 4756490 A 10-07-1990 BG 51358 A 15-04-1993 CA 2005704 A 16-06-1990 DK 115591 A 14-08-1991 EP 0449856 A 09-10-1991 FI 103122 B 30-04-1999 HU 58804 A 30-03-1992 JP 4503948 T 16-07-1992 MC 2178 A 22-05-1992 NO 304317 B 30-11-1998 RU2121481C 10-11-1998 WO9633739A31-10-1996AP 771 A 07-10-1999 AT 186842 T 15-12-1999 AU 693022 B 18-06-1998 AU5334596A 18-11-1996 AU 699213 B 26-11-1998 AU 6987398 A 23-07-1998 BG 101995 A 30-11-1998 BR 9608199 A 18-05-1999 CA 2217178 A 31-10-1996 CN 1182370 A 20-05-1998 CZ 9703379 A 18-03-1998 DE 69605296 D 30-12-1999 DE 69605296 T 18-05-2000 EP 0822831 A 11-02-1998 EP 0884056 A 16-12-1998 EP 0955059 A 10-11-1999 ES 2140076 T 16-02-2000 GR 3031912 T 29-02-2000 HU 9801560 A 28-10-1998 JP 11504020 T 06-04-1999 NO 974859 A 21-10-1997 NZ 305365 A 28-05-1999 PL 322968 A 02-03-1998 SI 822831 T 29-02-2000 SK 144297 A 06-05-1998 ZA 9602612 A 29-08-1996 WO9517209A29-06-1995AT 177322 T 15-03-1999 AU 1316495 A 10-07-1995 AU 687494 B 26-02-1998 AU 1316695 A 10-07-1995 AU 705521 B 27-05-1999 AU 6803198 A 09-07-1998 AU 705519 B 27-05-1999 AU 6803298 A 09-07-1998 CA 2179779 A 29-06-1995 CN 1138298 A 18-12-1996 DE 69417063 D 15-04-1999 DE 69417063 T 28-10-1999 DK 735898 T 23-08-1999 WO 9517210 A 29-06-1995 EP 0735898 A 09-10-1996 EP 0868918 A 07-10-1998 ES 2129801 T 16-06-1999 GR 3029750 T 30-06-1999 INTERNATIONALSEARCHREPORT lnterr ialApplicationNo Information on patent family members PCT% EP 00/02467 PatentdocumentPublicationPatentfamilyPublication citedinsearchreportdatemember(s)date WO9517209AJP9506887T08-07-1997 NZ277802A27-04-1998 SG49257A18-05-1998 SI735898T30-06-1999 ZA9410176A17-11-1995
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