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STABLE IMMUNOGENIC ANTIGEN COMPOSITIONS Staphylococcus aureus
专利权人:
УАЙТ ЭлЭлСи (US)
发明人:
ХАНДКЕ Лакшми (US),НОНОЯМА Акихиса (US),ХОДЖ Тамара Шефэр (US),НЕМА Сандип (US)
申请号:
RU2013128277/15
公开号:
RU2013128277A
申请日:
2011.12.21
申请国别(地区):
RU
年份:
2015
代理人:
摘要:
1. A lyophilized immunogenic composition comprising: (a) an isolated agglutinating factor A (ClfA) polypeptide Staphylococcus aureus, (b) a conjugate is a capsular polysaccharide of type 5 (CP5) protein, (c) a conjugate is a capsular polysaccharide of type 8 (CP8) a protein, (d) a buffer having a pKa of 6.0 ± 0.6, and (e) a bulking agent; wherein said ClfA polypeptide remains substantially non-degradable for at least 1 month at 37 ° C. 2. The lyophilized immunogenic composition of claim 1, wherein the composition further comprises an isolated MntC Staphylococcus aureus polypeptide. 3. The lyophilized immunogenic composition of claim 1, wherein the composition further comprises isolated agglutinating factor B (ClfB) Staphylococcus aureus. 4. The lyophilized immunogenic composition of claim 1, wherein the ClfA polypeptide contains an N domain. The lyophilized immunogenic composition of claim 1, wherein the ClfA polypeptide comprises a fibrinogen binding domain. The lyophilized immunogenic composition of claim 5, wherein the fibrinogen binding domain is altered to bind to fibrinogen at a reduced level compared to the observed binding of the native fibrinogen binding domain of ClfA to fibrinogen. The lyophilized immunogenic composition of claim 6, wherein the fibrinogen binding domain exhibits reduced binding to fibrinogen via available amino acid substitution at one or more of Tyr 338, Tyr 256, Pro 336, Lys 389, Ala 254 and Ile 387.8. The lyophilized immunogenic composition of claim 7, wherein the amino acid substitution at one or more of Tyr 338, Tyr 256, Pro 336, Lys 389, Ala 254, and Ile 387 is Ala or Ser. 9. The lyophilized immunogenic composition of claim 8, wherein Tyr 338 is substituted with Ala. 10. Lyophili1. Лиофилизированная иммуногенная композиция, содержащая:(a) выделенный полипептид агглютинирующего фактора A (ClfA) Staphylococcus aureus,(b) конъюгат - капсульный полисахарид типа 5 (CP5)-белок,(c) конъюгат - капсульный полисахарид типа 8 (CP8)-белок,(d) б
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