在COVID-19疫苗试验中实施和遵守定期无症状测试
Lucy R Williams1, Katherine R W Emary2, Daniel J Phillips2
1MRC Centre for Global Infectious Disease Analysis, School of Public Health, Imperial College London, London, United Kingdom.
Vaccine
|July 26, 2024
概括
在疫苗试验中,每周对无症状COVID-19感染进行测试是可行的. 守率为75%,可以检测出阳性病例,并为未来的疫苗疗效研究提供信息.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 传染性疾病 传染性疾病
- 临床试验 临床试验
背景情况:
- 对无症状感染的疫苗疗效 (VE) 的评估对于了解流行病学影响至关重要.
- 定期测试亚临床感染需要高参与者坚持和最小的假阳性.
- 本研究详细介绍了COVID-19疫苗试验中每周测试的实施和遵守情况.
研究的目的:
- 在COVID-19疫苗试验中评估每周无症状测试策略的可行性和遵守性.
- 分析影响遵守定期测试协议的因素.
- 估计检测真假阳性和假阳性无症状感染的概率.
主要方法:
- 在COV002试验中,每周使用自给RT-PCR扫描来检测无症状的SARS-CoV-2感染.
- 混合效应回归模型分析了坚持率.
- 真正和假阳性感染的概率是根据坚持和测试特征估计的.
主要成果:
- 在13个月内,由10,811名参与者进行了超过356,000次测试.
- 中位坚持率为75.0%,检测无症状感染的概率为74.5%.
- 坚持每周下降,受年龄,性别和职业的影响;在老年人,女性和非医疗保健工作者中观察到更高的坚持.
结论:
- COV002试验成功证明了长期无症状测试策略的可行性.
- 这些发现为设计未来的III期疫苗试验提供了宝贵的见解,其中感染是关键结果.
- 这种方法可以提高疫苗对传播影响的评估.
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