用动物模型替代的方法,用于对阳性原生疫苗的毒性评估
Martina Angela Checco1, Riccardo Villa1, Andrea Cacciamali2
1National Reference Center for Alternative Methods, Welfare and Care of Laboratory Animals, Istituto Zooprofilattico Sperimentale della Lombardia e dell'Emilia-Romagna-IZSLER, Via Bianchi 9, 25124 Brescia, Italy.
Research in veterinary science
|November 1, 2024
概括
自生疫苗的异常毒性测试 (ATT) 可以被体外方法所取代. 在评估疫苗毒性的MTT试验中,ATP试验表现出比MTT试验更高的灵敏度和精度.
科学领域:
- 药理学 药理学是指药理学的学科.
- 毒理学 毒理学 毒理学
- 疫苗开发 疫苗开发
背景情况:
- 异常毒性测试 (ATT) 是一种传统上用于自身疫苗释放和质量验证的体内测试.
- 目前的伦理和实践限制需要取消ATT作为参考方法.
- 更新监管框架和应用3Rs原则 (替代,减少,提炼) 在药品中至关重要.
研究的目的:
- 通过两项体外细胞活性试验,评估自身疫苗的潜在毒性.
- 为了比较MTT和ATP测试在评估疫苗诱导的细胞毒性的有效性.
- 为了确定传统的体内ATT的合适替代品.
主要方法:
- 自生疫苗被连续稀释 (基2稀释).
- 人类细胞用疫苗稀释剂进行治疗.
- 用MTT和ATP测试来评估细胞活力.
- 进行了MTT和ATP测定结果的比较分析.
主要成果:
- 在1:32或1:64的稀释下,ATP测试显示了良好的细胞活力.
- 该MTT测定产生了不一致的结果,表明疫苗即使在初始稀释时也不具有细胞毒性.
- 与MTT测定相比,ATP测定显示出更高的灵敏度和准确性.
结论:
- 由于其灵敏度和准确性,ATP测定是评估自身疫苗毒性的优先体外方法.
- 在体外细胞活力测试,特别是ATP,可以有效地取代传统的ATT.
- 采用ATP测定与3Rs原则保持一致,并使疫苗质量控制现代化.
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