Alt David P, Wilson-Welder Jennifer
Infectious Bacterial Diseases Research Unit, Agricultural Research Service, USDA, National Animal Disease Center, 1920 Dayton Avenue, Ames, IA 50010, USA.
Biologicals. 2013 Sep;41(5):323-4. doi: 10.1016/j.biologicals.2013.06.003. Epub 2013 Jul 6.
Evaluation of leptospiral vaccines for potency against Leptospira interrogans serovars Pomona, Icterohaemorrhagiae, Canicola, and Grippotyphosa is accomplished using the hamster potency test method described in 9 CFR 113.101-104. Applicability of this method to evaluation of bacterins developed for immunization against infection with L. interrogans serovar Hardjo or Leptospira borgpetersenii serovar Hardjo is complicated by several issues. Information from research on target host animal efficacy studies and evaluation of the immune response elicited using effective whole-cell bacterin formulations have revealed problems in relating these studies to either hamster-based or other potency testing methods. Future work on serovar Hardjo vaccines employing recombinant proteins will require preliminary testing methods in models other than the host animal. These models may also prove applicable to evaluation of potency for protein-based vaccines. Both an acute lethal infection model and a chronic infection model have been developed using two different strains of serovar Hardjo and will be described.
使用9 CFR 113.101 - 104中所述的仓鼠效力测试方法，对钩端螺旋体疫苗针对问号钩端螺旋体波摩那型、黄疸出血型、犬型和致热型血清型的效力进行评估。该方法在评估针对问号钩端螺旋体哈焦型血清型感染或博氏钩端螺旋体哈焦型血清型感染而研发的菌苗时，因若干问题而变得复杂。来自目标宿主动物效力研究以及使用有效的全细胞菌苗制剂引发的免疫反应评估的研究信息，揭示了将这些研究与基于仓鼠的或其他效力测试方法相关联时存在的问题。未来关于使用重组蛋白的哈焦型血清型疫苗的工作，将需要在宿主动物以外的模型中采用初步测试方法。这些模型也可能证明适用于评估基于蛋白质的疫苗的效力。已经使用哈焦型血清型的两种不同菌株开发了急性致死感染模型和慢性感染模型，并将予以描述。
