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淋化狂犬病mRNA疫苗免疫性,有效性和12个月存储稳定性的研究
Chen Chen1, Dandan Ling1, Kai Ji1
1Suzhou Abogen Biosciences Co., Ltd., Suzhou 215123, China.
Vaccines
|July 30, 2025
概括
一种新的mRNA-LNP狂犬病疫苗 (ABO1005) 的冷干燥使其能够稳定地在室温下储存. 与非活化疫苗相比,冷化疫苗表现出优越的免疫性和保护效果,为狂犬病预防提供了一个有希望的替代方案.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 生物技术是生物技术.
- 免疫学 免疫学 免疫学
背景情况:
- 目前的mRNA-LNP候选疫苗由于稳定性限制,需要冷储存.
- 这需要对长期存储和全球运输提出重大挑战.
- 开发热稳定的mRNA疫苗对于更广泛的可访问性至关重要.
研究的目的:
- 开发和评估一个冷干燥,热稳定的mRNA-LNP狂犬病疫苗 (ABO1005).
- 评估冷化疫苗的储存稳定性,免疫性,强度和保护功效.
- 为了比较ABO1005与商业化无活化狂犬病疫苗.
主要方法:
- 一种mRNA-LNP狂犬病疫苗 (ABO1005) 被制成并经过冷干燥.
- 在12个月的2-8°C下评估了储存稳定性.
- 评估了免疫性,疫苗效力 (NIH方法) 和保护效力 (狗的暴露后预防).
主要成果:
- 软化ABO1005表现出与其液体形式相比的免疫性,并诱导持续的幽默反应 (>175天).
- ABO1005引起的幽默和细胞免疫力明显高于无活化疫苗,并显示出高强度 (8.85 IU/剂量).
- 在暴露后,冷化疫苗在狗中提供了100%的保护,超过了非活化疫苗 (83%的保护).
- 经过12个月的冷藏储存后,没有观察到疫苗特征或免疫性显著变化.
结论:
- 一个稳定的,冷干燥的配方和流程为狂犬病mRNA疫苗 (ABO1005) 成功开发.
- 这种冷化mRNA候选疫苗提供了增强的热稳定性和卓越的疗效.
- 这些发现为未来冷化mRNA疫苗的开发铺平了道路.
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