在韩国开发的复合DTaP疫苗的安全性评估
Gi-Sub Choi1, Kyu-Ri Kang2, Seung-Bum Kim1
1CLIPS BnC, Research Center, Seoul, Korea.
Clinical and experimental vaccine research
|May 16, 2024
概括
一种新型重组性百日咳 (rP) 疫苗的安全性与现有的白喉 - - 细胞性百日咳 (DTaP) 疫苗相提并论. 这种rP疫苗没有显著的不良反应,这表明它是咳免疫的安全替代品.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 微生物学 微生物学
背景情况:
- 全细胞百日咳疫苗与不良反应有关.
- 细胞性百日咳 (aP) 和复合性百日咳 (rP) 疫苗正在作为更安全的替代品开发.
- 评估新型rP疫苗的安全性对于公共卫生至关重要.
研究的目的:
- 评估一种新的复合性百日咳 (rP) 疫苗的安全性.
- 为了比较新型rP疫苗的安全性与商业喉疹-细胞性百日咳 (DTaP) 疫苗的安全性.
主要方法:
- 使用了温度组胺敏感性测试 (HIST),CHO细胞测试,小鼠体重增加 (MWG) 测试,白细胞体促进 (LP) 测试和肌内炎性细胞因子测试.
- 测试了两种实验性重组DTaP (rDTaP) 疫苗,与两种对照DTaP疫苗进行了对比.
- 对残留的百日咳毒素 (PTx) 和各种系统和局部不良反应进行了评估.
主要成果:
- 在大多数组中没有检测到显著的残留PTx;在一个实验组中,数量最小.
- 在MWG测试或炎症性细胞因子测试中没有观察到显著的不良影响.
- 促进白血球细胞形成的测试显示中性粒细胞和淋巴细胞数量正常;在一些组中,单细胞的短暂增加.
结论:
- 新型rDTaP疫苗与现有的DTaP疫苗相比,在局部或全身不良反应方面没有显著差异.
- 没有发现与残留PTx相关的有关发现.
- 新型rDTaP疫苗被认为是安全的.
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