一种药物的安全性和免疫性
Kai Chu1, Zhao-Feng Bi2, Wei-Jin Huang3
1Jiangsu Provincial Center for Disease Control and Prevention, Public Health Research Institute of Jiangsu Province, Nanjing, Jiangsu, China.
The Lancet regional health. Western Pacific
|June 7, 2023
概括
一种由大肠杆菌生产的新型非价值HPV疫苗在第一阶段试验中显示出良好的安全性和免疫性. 建议对更广泛的人群和年龄组进行进一步的研究.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 免疫学 免疫学 免疫学
- 微生物生物技术 微生物生物技术
背景情况:
- 使用大肠杆菌 (大肠杆菌) 制造的双价HPV 16/18疫苗已获得世卫组织的预资格.
- 这项研究评估了通过大肠杆菌表达制造的第二代非价值HPV (9vHPV) 疫苗.
研究的目的:
- 评估新型9vHPV疫苗的安全性和免疫性.
- 评估候选疫苗的两个不同的剂量水平 (135微克和270微克).
主要方法:
- 一个单中心,开放标签,第一阶段剂量升级临床试验.
- 18-45岁的24名志愿者在0/1/6个月的时间表上接种疫苗.
- 对不良事件 (AE) 和严重不良事件 (SAE) 进行了监测;分析了血清IgG和中和抗体 (nAb) 水平.
主要成果:
- 副作用的发病率分别为66.7% (135微克) 和83.3% (270微克);所有这些都是轻度/中度,没有SAE.
- 没有观察到实验室参数的显著变化.
- 针对大多数HPV类型的IgG和nAbs的高血清转化率在第7个月实现.
结论:
- 由大肠杆菌生产的9vHPV疫苗初步耐受性良好且具有免疫性.
- 这些发现支持在更大的队列和不同年龄组的进一步临床开发.
关键词:
9-瓦伦特的 9-瓦伦特的埃舍里希亚大肠杆菌 (Escherichia coli) 是一个大肠杆菌.人类乳头瘤病毒疫苗疫苗免疫性 免疫性 免疫性第1期临床试验临床试验.安全的安全的安全的安全的安全.更多相关视频
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