在斯里兰卡销售的兽医狂犬病疫苗的效力
Hasanthi Rathnadiwakara1, Mangala Gunatilake1, Alexandre Servat2
1Department of Physiology, Faculty of Medicine, University of Colombo, Colombo 00800, Sri Lanka.
Vaccines
|May 27, 2023
概括
在斯里兰卡对兽医狂犬病疫苗的有效性测试显示,在8个品牌中,有4个品牌符合1.0 IU/剂量的最低要求. 这凸显了需要进行本地功效测试,以确保有效的动物免疫计划.
科学领域:
- 兽医免疫学 兽医免疫学
- 疫苗质量控制 疫苗质量控制
- 动物传染病预防和预防
背景情况:
- 斯里兰卡有七个兽医狂犬病疫苗品牌.
- 没有地方程序存在于发布前的疫苗效力测试.
- 确保疫苗的有效性对于控制动物狂犬病至关重要.
研究的目的:
- 评估斯里兰卡商业上可用的兽用狂犬病疫苗的效力.
- 用小鼠挑战测试来评估疫苗是否符合欧洲药典标准.
主要方法:
- 鼠标挑战测试是与欧盟/WOAH/世卫组织参考实验室合作进行的.
- 根据欧洲药典标准 (≥1.0 IU/剂量) 确定功效.
- 八种疫苗制剂 (单剂和多剂) 进行了测试.
主要成果:
- 四种单剂量疫苗 (RabisinTM,RaksharabTM,NobivacTM RL,NobivacTM 狂犬病) 满足了每剂量≥1.0 IU的要求.
- 三种单剂量疫苗 (CanvacTM R,DefensorTM 3,狂犬病杀死疫苗) 的有效性为<1.0 IU/剂量.
- 一种多剂量疫苗 (RaksharabTM多剂量) 的强度为1.3 IU/剂量,尽管该测试未经验证.
结论:
- 斯里兰卡的一些兽医狂犬病疫苗批量可能不符合所需的强度标准.
- 在市场上市之前实施局部功效测试对于有效的动物暴露前疫苗接种至关重要.
- 确保疫苗质量通过防止狂犬病传播来保护公共卫生.
相关概念视频
Vaccine Production
Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...
Rabies
Rabies is a lethal zoonotic disease caused by a single-stranded, negative-sense RNA virus of the Lyssavirus genus, within the family Rhabdoviridae. Its primary mode of transmission to humans is through bites or saliva-contaminated scratches from infected mammals such as dogs, bats, raccoons, or foxes. Transmission can also occur if infectious saliva contacts abraded skin or intact mucous membranes, including the conjunctiva.Viral Entry and Early ReplicationOnce introduced at the bite or scratch...


