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    • 8. 发明申请
    • ADJUVANTING MENINGOCOCCAL FACTOR H BINDING PROTEIN
    • WO2010109323A1
    • 2010-09-30
    • PCT/IB2010/000733
    • 2010-03-24
    • NOVARTIS AGCONTORNI, MarioTARLI, Lorenzo
    • CONTORNI, MarioTARLI, Lorenzo
    • A61K39/095
    • A61K39/095A61K47/02A61K2039/55505A61K2039/55583A61K2039/6018A61K2039/70
    • Factor H binding protein (fHBP) has been proposed for use in immunising against serogroup B meningococcus ('MenB'). This antigen can be efficiently adsorbed to an aluminium hydroxyphosphate adjuvant by (i) ensuring that adsorption takes place at a pH which is equal to or below the adjuvant's point of zero charge (PZC), and/or (ii) selecting a fHBP and adjuvant with an isoelectric point/PZC within the range of 5.0 to 7, and/or (iii) selecting a fHBP with an isoelectric point above the adjuvant's PZC and using a buffer to bring the pH to within 1.2 pH units of the PZC. The adsorption is particularly useful for compositions which include multiple fHBP variants, and also in situations where an aluminium hydroxide adjuvant should be avoided. Buffered pharmaceutical compositions can include at least two different meningococcal fHBP antigens, both of which are at least 85% adsorbed to aluminium hydroxyphosphate adjuvant.
    • 已经提出因子H结合蛋白(fHBP)用于免疫血清群B脑膜炎球菌('MenB')。 (i)确保在等于或低于佐剂点零点(PZC)的pH下进行吸附,和/或(ii)选择fHBP和佐剂,可以有效地将该抗原吸附到羟基磷酸铝佐剂上 等电点/ PZC在5.0至7范围内,和/或(iii)选择具有等电点高于佐剂PZC的fHBP,并使用缓冲液使pH达到PZC的1.2pH单位内。 该吸附对于包含多种fHBP变体的组合物以及在应避免使用氢氧化铝佐剂的情况下特别有用。 缓冲的药物组合物可以包括至少两种不同的脑膜炎球菌fHBP抗原,两者都至少85%被羟基磷酸羟丙酯佐剂吸附。