REACTIONS FOLLOWING IMMUNIZATION WITH JAPANESE ENCEPHALITIS VIRUS VACCINE

接种日本脑炎病毒疫苗后的反应

• 批准号: 3804818
• 负责人: L A SAWYER
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3804818
• 关键词: Japanese encephalitis virus; allergens; drug adverse effect; drug quality /standard; epidemiology; gelatin; human subject; hypersensitivity; immunoglobulin E; protamines; serum; viral vaccines

Japanese encephalitis virus is the causative agent of an acute inflammatory illness of the central nervous system found throughout eastern Asia. A formalin activated, mouse-brain derived Japanese encephalitis virus vaccine has been developed. A report of severe urticarial reactions associated with immunization with Japanese encephalitis virus vaccine was published in the Lancet. The rate of severe side-effects was reported to be 0.04%. The description of the adverse reactions was similar to allergic reactions seen when booster doses of rabies vaccine were given. The Centers for Disease Control were invited to participate in an investigation of the patients. A case control study is planned. We will obtain sera for testing for IgE antibodies by the RAST test. The patients will be skin tested with the vaccine lot associated with the reaction, another vaccine lot produced using an earlier manufacturing method, and a recently prepared lot. We have reviewed the vaccine manufacturing scheme to identify steps in manufacture of components of the vaccine that may be allergenic. We will be examining sera for antibodies to gelatin and protamine sulfate. If the allergen can be identified then the manufacturing process will be reviewed and alternatives will be sought to exclude the allergen. If the cause of the allergic reactions cannot be removed or cannot be defined, a warning indicating the possibility of this adverse reaction will be added to the package insert.

日本脑炎病毒是急性乙型脑炎的病原体， 中枢神经系统的炎症性疾病， 东亚。 一种福尔马林激活的，老鼠脑衍生的日本 已经研制出脑炎病毒疫苗。 报告称， 与日本疫苗接种相关的荨麻疹反应 脑炎病毒疫苗发表在《柳叶刀》上。 率 据报道，严重副作用为0.04%。 的描述 不良反应类似于加强免疫时的过敏反应。 注射狂犬病疫苗。 疾病控制中心 被邀请参加对病人的调查。 的情况 计划进行对照研究。 我们将采集血清进行IgE检测 RAST测试的抗体。 患者将接受皮肤测试， 与反应相关的疫苗批次，生产的另一个疫苗批次 使用较早的制造方法和最近制备的批次。 我们 已经审查了疫苗生产计划，以确定 疫苗中可能引起过敏的成分的生产。 我们将 检查血清中明胶和硫酸鱼精蛋白的抗体 如果 可以确定过敏原，然后将审查生产过程 并将寻求替代方案以排除过敏原。 如果原因是 过敏反应无法消除或无法定义，警告 表明这种不良反应的可能性将被添加到 包装说明书。