世界范围内的麻疹疫苗株及其应用课件.ppt

沪191株和国际麻疹疫苗株的比较 成都生物制品研究所 病毒疫苗研究室 Edmonston-Zargreb和沪191麻疹疫苗免疫婴儿的血清学研究 刘伟，陈杰，王树声等 国内外几种麻疹减毒活疫苗免疫持久性研究 王树声，苏万年，吴绍源，迮文远，蔡日芬，崔君兆，陈杰，章以浩 以麻疹为基础的联苗疫苗株 成都生物制品研究所 病毒疫苗研究室 BRDII S79 Hu-191 上海所 Takahashi strain Hoshino strain AIK-C 日本北里研究所 Wistar RA 27/3 strain RIT 4385 strain Schwarz strain GSK Wistar RA 27/3 strain Jeryl LynnTM (B level) strain Moraten strain Merck Rubella Mumps Measle WHO-TRS对麻疹疫苗株的规定 成都生物制品研究所 病毒疫苗研究室 A.2 Certification of the strain of virus for use in vaccine production The strain of measles virus used in the production of measles vaccine shall be identified by historical records that include information on the origin of the strain, its method of attenuation and the passage level at which attenuation was demonstrated by clinical evaluation. The strain of measles virus used in the production of vaccine shall have been shown to be safe by appropriate laboratory tests (see section A.4 of these Requirements) and safe and imrnunogenic by tests in susceptible humans. Only strains that are certified by the national control authority shall be used. The lowest immunizing dose of virus in the vaccine that induces seroconversion in susceptible individuals shall be established in a dose-response study. This dose shall serve as a basis for establishing parameters for stability and expiry of the vaccine. ? A.4.1.1 Strain of measles virus The strain of measles virus used in the production of live measles vaccine shall be certified according to the specifications of section A.2. The vaccine strain shall be approved by the national control authority. The seed lot or five consistent lots of vaccine derived from the seed lot shall have been shown to be non-neuropathogenic in monkeys (see section A.4.2.1) and to yield live measles vaccine of adequate immunogenicity and safety in human beings. EP对麻疹疫苗株的规定 成都生物制品研究所 病毒疫苗研究室 DEFINITION Measles vaccine (live) is a freeze-dried preparation of a suitable attenuated strain of measles virus. The vaccine is reconstitut