The acceptance of serology data instead of challenge for market release of new batches of commercial vaccine is under evaluation by regulatory agencies in order to reduce the use of animals and costs for manufacturers. In this study two vaccines for Bluetongue virus serotype 8 were submitted to quality controls required by the European Pharmacopoeia and tested on sheep in comparison with a commercial inactivated vaccine. Body temperature, antibody titres and viraemia of vaccinated and controls sheep were recorded. In addition IL4 and IFNγ in sera and supernatant derived from in vitro stimulation of blood cells were also quantified using two commercial ELISA kit. The outer-capsid protein VP2 contained in vaccine formulations was quantified using a home-made capture-ELISA. Results obtained indicates that in-lab evaluation of cell-mediated and humoral immune response are useful parameters to predict the efficacy of BTV inactivated vaccines avoiding the challenge phase required to release new batches of vaccines with proven clinical efficacy and safety. The correlation observed between serology data and VP2 protein concentration of final product could be useful in-process control to predict if a new vaccine batch of BTV must be discarded or released to the market.

中文翻译：

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减少动物在灭活BTV8蓝舌病疫苗质量控制中的替代方法。

为了减少动物的使用并降低制造商的成本，监管机构正在评估接受血清学数据，而不是挑战新批商业疫苗的市场发布挑战。在这项研究中，两种针对蓝舌病毒血清型8的疫苗已提交欧洲药典要求的质量控制，并与商用灭活疫苗进行了对比。记录了接种羊和对照羊的体温，抗体滴度和病毒血症。此外，还使用两种市售ELISA试剂盒对血清和体外刺激血细胞的上清液中的IL4和IFNγ进行了定量。使用自制的捕获ELISA对疫苗制剂中包含的衣壳蛋白VP2进行定量。所获得的结果表明，对细胞介导的和体液免疫反应的实验室评估是预测BTV灭活疫苗功效的有用参数，从而避免了释放具有新的临床功效和安全性的新批次疫苗所需的挑战阶段。血清学数据与最终产品VP2蛋白浓度之间观察到的相关性可用于进行过程控制，以预测是否必须丢弃新一批的BTV疫苗或将其投放市场。