JP2008535838A5 - - Google Patents

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JP2008535838A5
JP2008535838A5 JP2008505426A JP2008505426A JP2008535838A5 JP 2008535838 A5 JP2008535838 A5 JP 2008535838A5 JP 2008505426 A JP2008505426 A JP 2008505426A JP 2008505426 A JP2008505426 A JP 2008505426A JP 2008535838 A5 JP2008535838 A5 JP 2008535838A5
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immunogenic composition
adjuvant
aluminum
crm
carrier protein
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本特許出願に特定されている全ての学術論文、他の参考文献、特許、および特許出願は、参照によってその全体が組み込まれる。
参考文献
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2.Hausdorff WP, Bryant J, Kloek C, Paradiso PR, Siber GR. The contribution of specific pneumococcal serogroups to different disease manifestations: implications for conjugate vaccine formulation and use, part I. Clin Infect Dis 2000; 30:122-40.
3.Whitney CO, Farley MM, Nadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. New Engl J Med 2003; 348(18):1737-46.
4.Black S, Shinefield H, Hansen J, et al. Postlicensure evaluation of the effectiveness of seven valent pneumococcal conjugate vaccine. Pediatr Infect Dis J 2001; 20;1105-7.
5.Robinson KA, Baughman W, Rothrock G, at al. Epidemiology of invasive Streptococcus pneumoniae infections in the United States, 1995-1998: Opportunities for prevention in the conjugate vaccine era. JAMA 2001; 285:1729-35.
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7.Whitney CO, Farley MM, Nadler J, et al. Increasing prevalence of multidrug-resistant Streptococcus pneumoniae in the United States. N EngI J Med 2000; 343:1917-24.
8.Hofmann J, Cetron MS, Farley MM, et al. The prevalence of drug-resistant Streptococcus pneumoniae in Atlanta. N Engi J Med 1995; 333:481-6.
9.Joloba ML, Windau A, Bajaksouzian S, Appelbaum PC Hausdorff WP, Jacobs MR. Pneumococcal conjugate vaccine serotypes of Streptococcus pneumoniae isolates and the antimicrobial susceptibility of such isolates in children with otitis media. Clin Infect Dis 2001; 33:1489-94.
10.Black S, Shinefield H, Fireman B, et al. Efficacy, safety, and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J 2000; 19:187-95.
11.Rudolph KM, Parkinson AJ, Reasonover AL, Bulkow LR, Parks DJ, Butler JC. Serotype distribution and antimicrobial resistance pattenrs of invasive isolates of Streptococcus pneumoniae: Alaska, 1991-1998. J Infect Dis 2000; 182:490-6.
12.Sniadack DH, Schwartz B, Lipman H, et al. Potential interventions for the prevention of childhood pneumonia: geographic and temporal differences in serotype and serogroup distribution of sterile site pneumococcal isolates from children: implications for vaccine strategies. Pediatr Infect Dis J 1995; 14:503-10.
13.Fagan RL, Hanna JN, Messer RD, Brookes DL, Murphy DM. The epidemiology of invasive pneumococcal disease in children in Far North Queensland. J. Paediatr Child Health 2001; 37:571-5.
14.Kertesz DA, DI Fabio JL, de Cunto Brandileone MC, et al. Invasive Streptococcus pneumoniae infection in Latin American children: results of the Pan American Health Organization Surveillance. Study. Clin Infect Dis 1998; 26:1355-61.
15.Hausdorff W, Sitter G, Paradiso P. Geographical differences in invasive pneumococcal disease rates and serotype frequency in young children. Lancet 2001; 357:950-52.
16.Buckingham SC, King MD, Miller ML. Incidence and etiologies of complicated parapneumonic effusions in children, 1996 to 2001. Pediatr Infect Dis J 2003; 22:499-504.
17.Byington C, Spencer L, Johnson T, et al. An epidemiological investigation of a sustained high rate of pediatric parapneumonic empyema: risk factors and microbiological associations. Clin Infect Dis 2002; 34:434-40.
18.Tan T, Mason E, Wald E, et al. Clinical characteristics with complicated pneumonia caused by Streptococcus pneumoniae. Pediatrics 2002; 110:1-6.
19.Block SL, Hedrick J, Harrison CJ, et al. Pneumococcal serotypes from acute otitis media in rural Kentucky. Pediatr Infect Dis J 2002; 21:859-65.
20.Hausdorff WP, Yothers G, Dagan R, et al. Multinational study of pneumococcal serotypes causing acute otitis media in children. Pediatr Infect Dis J 2002; 21:1008-16.
21.Robbins JB, Austrian R, Lee CJ, et al. Considerations for formulating the second-generation pneumococcal capsular polysaccharide vaccine with emphasis on the cross-reactive types within groups. J Infect Dis 1983; 148:1136-59.
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24.Vakevainen M, Eklund C, Eskola J, Kayhty H. Cross-reactivity of antibodies to type 6B and 6A polysaccharides of Streptococcus pneumoniae, evoked by pneumococcal conjugate vaccines, in infants. J Infect Dis 2001; 184:789-93.
25.Ekstrom N, Kilpi T, Landenkari M, Lehtonen H, Ahman H, Kayhty, H. Immune response to cross-reacting pneumococcal serotypes 6A16B and 19N19F in the FinOM vaccine trial, Third World of Congress of Pediatric Infectious Diseases, Santiago, Chile, November 19-23, 2003.
26.Penn RL, Lewin EB, Douglas RG, Jr., Schifiman G, Lee CJ, Robbins JB. Antibody responses in adult volunteers to pneumococcal polysaccharide types 19F and 19A administered singly and in combination. Infect Immun 1982; 36:1261-2.
27.Giebink GS, Meier JD, Quartey MK, Liebeler CL, Le CT. Immunogenicity and efficacy of Streptococcus pneumoniae polysaccharide-protein conjugate vaccines against homologous and heterologous serotypes in the chinchilla otitis media model. J Infect Dis 1996; 173:119-27.
28.Saeland E, Jakobsen H, Ingolfsdottir G, Sigurdardottir ST, Jonsdottir I. Serum samples from infants vaccinated with a pneumococcal conjugate vaccine, PncT, protect mice against invasive infection caused by Streptococcus pneumoniae serotypes 6A and 6B. J Infect Dis 2001; 183:253-60.
29.Jakobsen H, Sigurdsson VD, Sigurdardottir S, Schulz D, Jonsdottir I. Pneumococcal serotype 19F conjugate vaccine induces cross-protective immunity in serotype 19A in a murine pneumococcal pneumonia model. Infect Immun 2003; 71:2956-9.
30.Klugman KP, Madhi SA, Huebner RE, Kohberger R, Mbelle N, Pierce N. A trial of a 9-valent pneumococcal conjugate vaccine in children with and those without HIV infection. N Engi J Med 2003; 349;1341-8.
31.O'Brien KL, Moulton LH, Reid R, et al. Efficacy and safety of seven-valent conjugate pneumococcal vaccine in American Indian children: group randomised trial. Lancet 2003; 362:355-61.
32.Eskola J, Kilpi T, Palmu A, et al. Efficacy of a pneumococcal conjugate vaccine against acute otitis media. N Engi J Med 2001: 344:403-9.
33.Pilishvili T, Farley M, Vazquez M, Reingold A, Nyquist A, et al. Effectiveness of heptavalent pneumococcal conjugate vaccine in children. Abst G-1079, ICAAC, Chicago, IL, 2003.
34.U.S. Patent No. 4,673,574.
35.U.S. Patent No. 4,902,506.

Claims (17)

  1. 13種類の異なる多糖類−タンパク質コンジュゲートを、生理学的に許容できるビヒクルと共に含む多価免疫原性組成物であって、そのコンジュゲートの各々がCRM 197 キャリアタンパク質にコンジュゲートしたストレプトコッカスニューモニエの異なる血清型からの莢膜多糖類を含み、その莢膜多糖類が血清型1、3、4、5、6A、6B、7F、9V、14、18C、19A、19Fおよび23Fから調製され、その各莢膜多糖類が別々にCRM 197 キャリアタンパク質にコンジュゲートしている、多価免疫原性組成物。
  2. さらにアジュバントを含む、請求項1記載の免疫原性組成物。
  3. アジュバントがアルミニウムをベースとするアジュバントであるところの、請求項記載の免疫原性組成物。
  4. アジュバントがリン酸アルミニウム、硫酸アルミニウムおよび水酸化アルミニウムからなる群より選択されるところの、請求項記載の免疫原性組成物。
  5. アジュバントがリン酸アルミニウムであるところの、請求項記載の免疫原性組成物。
  6. ストレプトコッカスニューモニエ莢膜多糖類コンジュゲートに対する免疫応答を誘発するための医薬の製造における、請求項1に記載の免疫原性組成物の使用
  7. 投与される免疫原性組成物が、0.5mLの単回用量にて、6Bを4μgとすることを除き、各糖類を2μgにて;CRM197キャリアタンパク質を約29μgにて;アルミニウム元素を0.125mg(リン酸アルミニウムを0.5mg)のアジュバントにて;ならびに賦形剤としての塩化ナトリウムおよびコハク酸ナトリウム緩衝液を含有するように処方されるところの、請求項記載の使用
  8. さらに、ネイセリアメニンジタイディスタイプBからの1種または複数のタンパク質を含む、請求項1記載の免疫原性組成物。
  9. 多糖類−タンパク質コンジュゲートを生理学的に許容できるビヒクルと共に含む多価免疫原性組成物であって、そのコンジュゲートの各々がCRM 197 キャリアタンパク質にコンジュゲートしたストレプトコッカスニューモニエの異なる血清型からの莢膜多糖類を含み、その莢膜多糖類が血清型3および少なくとも1種類の付加的な血清型から調製され、その各莢膜多糖類が別々にCRM 197 キャリアタンパク質にコンジュゲートしている、多価免疫原性組成物。
  10. 付加的な血清型が血清型1、4、5、6A、6B、7F、9V、14、18C、19A、19Fおよび23Fからなる群より選択されるところの、請求項9記載の免疫原性組成物。
  11. さらにアジュバントを含む、請求項9記載の免疫原性組成物。
  12. アジュバントがアルミニウムをベースとするアジュバントであるところの、請求項11記載の免疫原性組成物。
  13. アジュバントがリン酸アルミニウム、硫酸アルミニウムおよび水酸化アルミニウムからなる群より選択されるところの、請求項12記載の免疫原性組成物。
  14. アジュバントがリン酸アルミニウムであるところの、請求項13記載の免疫原性組成物。
  15. ストレプトコッカスニューモニエ莢膜多糖類コンジュゲートに対する免疫応答を誘発するための医薬の製造における、請求項9に記載の免疫原性組成物の使用
  16. 投与される免疫原性組成物が、0.5mLの単回用量にて、6Bを4μgとすることを除き、各糖類を2μgにて;CRM197キャリアタンパク質を約29μgにて;アルミニウム元素を0.125mg(リン酸アルミニウムを0.5mg)のアジュバントにて;ならびに賦形剤としての塩化ナトリウムおよびコハク酸ナトリウム緩衝液を含有するように処方されるところの、請求項15記載の使用
  17. さらに、ネイセリアメニンジタイディスタイプBからの1種または複数のタンパク質を含む、請求項9記載の免疫原性組成物。
JP2008505426A 2005-04-08 2006-03-31 多価肺炎球菌多糖類−タンパク質コンジュゲート組成物 Active JP4472770B2 (ja)

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KR (11) KR20150061019A (ja)
CN (6) CN113198012A (ja)
AR (2) AR053354A1 (ja)
AT (1) ATE548051T1 (ja)
AU (1) AU2006235013B2 (ja)
BR (1) BRPI0607025B8 (ja)
CA (4) CA3165042A1 (ja)
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PL (1) PL1868645T3 (ja)
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RS (1) RS52249B (ja)
SA (1) SA06270323B1 (ja)
SI (1) SI1868645T1 (ja)
TW (3) TWI511739B (ja)
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