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    • 1. 发明授权
    • Method for identifying attenuated chickenpox virus Oka strain or strain
originating therein and acceptable as attenuated chickenpox vaccine
virus
    • 用于鉴定减毒水痘病毒Oka菌株或由其衍生的菌株的方法
    • US6093535A
    • 2000-07-25
    • US983045
    • 1998-01-15
    • Chisato MoriRie TakaharaJuichiro OsameYasuyuki GomiIsao Fuke
    • Chisato MoriRie TakaharaJuichiro OsameYasuyuki GomiIsao Fuke
    • A61K39/00C07K14/04C12N15/38C12Q1/70C07H21/04C12N7/00C12P19/34
    • C07K14/005C12Q1/701A61K39/00C12N2710/16722
    • Disclosed is a method for exact identification of the attenuated varicella virus Oka strain or a strain derived therefrom capable of functioning as an attenuated varicella live vaccine virus, which comprises analyzing the difference in the genomic DNA and fragments thereof between the Oka strain and a sample varicella strain, and determining whether or not a sample strain satisfies all of the following eight characteristics: the sizes of the HpaI-K fragment and the EcoRI-P fragment; the size of R2-487 region of Gene14 and the analysis by PCR-SSCP; the sizes of the restriction fragments obtained by digesting the R2-1764 fragment with AccIII; the absence or presence of a PstI cleavage site; the homology of the amino acid sequences coded by R2-487 coding region; and the homology of the amino acid sequences coded by the coding region of VZV Gene14. The method of the present invention is extremely useful for the quality control and quality assurance of attenuated varicella live vaccines. Also disclosed are an isolated virus strain which is substantially the same virus strain as identified by the above method; an attenuated varicella virus live vaccine comprising the same virus strain as identified by the above method; an attenuated varicella virus Oka strain antigen; and a pair of primers which are advantageously, effectively usable in the above method.
    • PCT No.PCT / JP97 / 01646 Sec。 371日期1998年1月15日 102(e)日期1998年1月15日PCT提交1997年5月15日PCT公布。 公开号WO97 / 43420 PCT 日期1997年11月20日公开是一种精确鉴定减毒水痘病毒Oka菌株或由其衍生的能够作为减毒水痘活疫苗病毒的菌株的方法,其中包括分析Oka基因组DNA及其片段之间的差异 菌株和样本水痘菌株,并确定样品菌株是否满足以下八个特征:HpaI-K片段和EcoRI-P片段的大小; Gene14的R2-487区域的大小和通过PCR-SSCP的分析; 通过用AccIII消化R2-1764片段获得的限制性片段的大小; 不存在或存在PstI切割位点; 由R2-487编码区编码的氨基酸序列的同源性; 和由VZV Gene14的编码区编码的氨基酸序列的同源性。 本发明的方法对于减毒水痘活疫苗的质量控制和质量保证是非常有用的。 还公开了分离的病毒株,其通过上述方法鉴定为基本上相同的病毒株; 包含由上述方法鉴定的相同病毒株的减毒水痘病毒活疫苗; 减毒水痘病毒Oka株抗原; 以及有利地在上述方法中有效使用的一对引物。
    • 2. 发明授权
    • Stabilized live vaccine
    • 稳定活疫苗
    • US6039958A
    • 2000-03-21
    • US179970
    • 1998-10-28
    • Kuniaki KoyamaJuichiro Osame
    • Kuniaki KoyamaJuichiro Osame
    • A61K39/25A61K39/295A61P31/12A61P31/22A01N63/00A61K39/12
    • A61K39/25A61K39/0015A61K39/12A61K2039/5254A61K2039/70C12N2710/16734
    • A stabilized live vaccine containing a varicella virus and a stabilizer, wherein the vaccine is substantially free of Ca.sup.2+ ions and Mg.sup.2+ ions is described. This stabilized live vaccine is excellent in storage stability and heat resistance. Also described is an improved stabilizer for a live varicella vaccine, comprising at least gelatin or hydrolyzed gelatin, each being substantially free of Ca.sup.2+ ions and Mg.sup.2+ ions. The stabilizer can advantageously be used to stabilize a live vaccine containing a varicella virus. The substantial freedom of Ca.sup.2+ ions and Mg.sup.2+ ions can be attained by masking Ca.sup.2+ ions and Mg.sup.2+ ions present in a live vaccine containing a varicella virus and a stabilizer, with a chelating reagent, or by using as a stabilizer gelatin and/or a gelatin derivative after being purified to remove Ca.sup.2+ ions and/or Mg.sup.2+ ions contained therein.
    • 含有水痘病毒和稳定剂的稳定的活疫苗,其中疫苗基本上不含Ca 2+离子,描述了Mg 2+离子。 这种稳定的活疫苗具有优异的储存稳定性和耐热性。 还描述了一种用于活水痘疫苗的改进的稳定剂,其包含至少明胶或水解明胶,其各自基本上不含Ca 2+离子和Mg 2+离子。 稳定剂可以有利地用于稳定含有水痘病毒的活疫苗。 通过用螯合剂掩蔽含有水痘病毒和稳定剂的活疫苗中的Ca 2+离子和Mg 2+离子,或通过使用明胶和/或明胶衍生物作为稳定剂,可以获得Ca 2+离子和Mg 2+离子的实质自由度 经纯化以除去其中所含的Ca 2+离子和/或Mg 2+离子。
    • 6. 发明授权
    • Stabilized live vaccine
    • 稳定活疫苗
    • US5948411A
    • 1999-09-07
    • US322036
    • 1994-10-12
    • Kuniaki KoyamaJuichiro Osame
    • Kuniaki KoyamaJuichiro Osame
    • A61K39/25A61K39/295A61P31/12A61P31/22A61K39/165A61K39/12C12N7/00C12N7/04
    • A61K39/25A61K39/0015A61K39/12A61K2039/5254A61K2039/70C12N2710/16734
    • Disclosed is a stabilized live vaccine containing a varicella virus and a stabilizer, wherein the vaccine is substantially free of Ca.sup.2+ ions and Mg.sup.2+ ions. This stabilized live vaccine is extremely excellent in storage stability and heat resistance. Also disclosed is an improved stabilizer for a live varicella vaccine, comprising at least one member selected from gelatin and hydrolyzed gelatin, each being substantially free of Ca.sup.2+ ions and Mg.sup.2+ ions. The stabilizer can advantageously be used to stabilize a live vaccine containing a varicella virus. The substantial freedom of Ca.sup.2+ ions and Mg.sup.2+ ions can be attained by masking Ca.sup.2+ ions and Mg.sup.2+ ions present in a live vaccine containing a varicella virus and a stabilizer, with a chelating reagent, or by using as a stabilizer gelatin and/or a gelatin derivative after being purified to remove Ca.sup.2+ ions and/or Mg.sup.2+ ions contained therein.
    • 公开了含有水痘病毒和稳定剂的稳定的活疫苗,其中疫苗基本上不含Ca 2+离子和Mg 2+离子。 这种稳定的活疫苗在储存稳定性和耐热性方面非常优异。 还公开了一种用于活水痘疫苗的改进的稳定剂,其包含至少一种选自明胶和水解明胶的成分,各自基本上不含Ca 2+离子和Mg 2+离子。 稳定剂可以有利地用于稳定含有水痘病毒的活疫苗。 通过用螯合剂掩蔽含有水痘病毒和稳定剂的活疫苗中的Ca 2+离子和Mg 2+离子,或通过使用明胶和/或明胶衍生物作为稳定剂,可以获得Ca 2+离子和Mg 2+离子的实质自由度 经纯化以除去其中所含的Ca 2+离子和/或Mg 2+离子。