复合腺病毒类型-5载体COVID-19疫苗的安全性,耐受性和免疫性:一个剂量升级的,开放的,非随机的,首次对人进行的试验
Feng-Cai Zhu1, Yu-Hua Li2, Xu-Hua Guan3
1NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Lancet (London, England)
|May 26, 2020
概括
这一第一阶段试验发现腺病毒类型-5 (Ad5) 载体的COVID-19疫苗是安全和免疫的. Ad5 COVID-19 疫苗显示出可容忍的安全性,并诱导显著的抗体和T细胞反应.
科学领域:
- 疫苗学
- 免疫学
- 病毒学
背景情况:
- 迫切需要一个COVID-19疫苗.
- 对表达SARS-CoV-2尖端糖蛋白的新型重组腺病毒类型-5 (Ad5) 载体疫苗的评估.
研究的目的:
- 评估Ad5载体COVID-19疫苗的安全性和免疫性.
- 在健康成年人中确定最佳剂量和免疫反应.
主要方法:
- 第一个阶段,剂量升级,单中心,开放试验.
- 108名健康成年人 (18至60岁) 接受了三剂Ad5疫苗之一.
- 在28天内评估安全性;通过抗体和T细胞测定测量免疫性.
主要成果:
- 大多数不良反应为轻度/ 中度 (疼痛,发烧,疲劳,头痛).
- 在28天内没有报告严重不良事件.
- 在14日观察到ELISA,中和抗体和T细胞反应的显著增加,在28日达到峰值.
结论:
- 这种Ad5载体的COVID-19疫苗表现出良好的耐受性和免疫性.
- 在接种疫苗后28天,幽默和细胞免疫反应达到峰值.
- 需要对这种Ad5 COVID-19疫苗进行进一步的研究.
相关概念视频
Bioavailability Study Design: Healthy Subjects Versus Patients
83
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
83
Bioavailability Study Design: Single Versus Multiple Dose Studies
129
Bioavailability studies are essential for understanding how a drug is absorbed, distributed, metabolized, and excreted in the body. These studies assess the extent and rate at which the active pharmaceutical agent becomes available at the site of action. The design of bioavailability studies can involve single-dose or multiple-dose regimens, each with distinct advantages and limitations.Single-dose studies are the preferred approach due to their simplicity and reduced drug exposure for...
129


