将优化的COVID-19疫苗计划带给免疫功能低下的人群:统计元素和设计
Michael Dymock1,2, James H McMahon3,4,5, David Griffin3,5
1Wesfarmers Centre of Vaccines and Infectious Diseases, The Kids Research Institute Australia, 15 Hospital Avenue, Nedlands, 6009, Perth, Australia. michael.dymock@thekids.org.au.
澳大利亚的BOOST-IC试验优化了对免疫功能低下的澳大利亚人的COVID-19助推剂时间表. 它评估使用Pfizer,Moderna或Novavax疫苗的一剂或两剂方案,以确定最佳的免疫反应和安全性.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 临床试验 临床试验
背景情况:
- 免疫功能低下的人群表现出减少的疫苗反应.
- 优化COVID-19增强剂时间表对于这个弱势群体至关重要.
- 了解变种保护对于公共卫生至关重要.
研究的目的:
- 评估不同COVID-19助推剂计划的免疫性,安全性和交叉保护.
- 为了在免疫受损的个体中比较单剂量与两剂量增强剂方案.
- 评估Pfizer,Moderna和Novavax疫苗在特定免疫受损子群体中的疗效.
主要方法:
- 多站点,自适应平台试验设计.
- 将参与者随机分配到三个免疫受损亚群之一 (HIV,SOT,血液恶性瘤).
- 使用三种COVID-19疫苗品牌进行一次或两剂剂量增强剂计划的管理.
主要成果:
- 主要终点:在接种疫苗后28天的SARS-CoV-2抗高峰IgG度.
- 用于数据分析的贝叶斯分层两部分模型,考虑试验检测极限.
- 以预先规定的决策标准为指导的试验调整.
结论:
- 该BOOST-IC试验提供了针对免疫功能低下个体的最佳COVID-19疫苗接种策略的关键数据.
- 调查结果将为在高风险人群中进行再接种疫苗的公共卫生建议提供信息.
- 适应性设计允许对多种疫苗计划和品牌进行有效评估.
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