基于RNA和基于蛋白质的信使COVID-19疫苗的真实世界的有效性和非劣势评估和比较:与混合有效性设计的BEEHIVE随机研究的协议
Sarang K Yoon1, German L Ellsworth2, Steph Battan-Wraith3
1Division of Occupational and Environmental Health, School of Medicine, University of Utah, Salt Lake City, UT, United States.
JMIR research protocols
|January 27, 2026
概括
促进健康,疾病和疫苗有效性的流行病学评估 (BEEHIVE) 研究评估了更新的Novavax和Pfizer-BioNTech COVID-19疫苗的现实疫苗有效性. 结果将为针对不断演变的SARS-CoV-2变种的持续公共卫生策略提供信息.
科学领域:
- 免疫学 免疫学 免疫学
- 流行病学 流行病学
- 公共卫生 公共卫生
背景情况:
- 在2023年5月疫情结束后,COVID-19疫苗有效性 (VE) 监测下降.
- 持续监测最新的疫苗配方对于保持VE对新出现的SARS-CoV-2变种至关重要.
- 促进健康,疾病和疫苗有效性的流行病学评估 (BEEHIVE) 研究解决了这一需求.
研究的目的:
- 评估2023-2024年Novavax和Pfizer-BioNTech的COVID-19疫苗配方的现实世界 VE.
- 为了比较Novavax和Pfizer-BioNTech更新的COVID-19疫苗之间的相对VE.
- 探索影响VE的因素,包括先前的疫苗接种史和COVID-19后的情况.
主要方法:
- 一个随机的混合设计试验 (NCT06065176) 招募了约1500名在犹他州盐湖城的成年人.
- 参与者接受了Novavax或Pfizer-BioNTech 2023-2024疫苗配方,或是观察对照组的一部分.
- 24周的随访包括每周的症状调查和自我管理的抗原测试,以确定针对症状性SARS-CoV-2感染的VE.
主要成果:
- 招募发生在2023年11月至2024年3月期间,452名参与者被随机分配到Novavax,457名参与者被分配到Pfizer-BioNTech,279名参与者被分配到对照组.
- 流传的SARS-CoV-2变种包括XBB,JN.1,KP.2和KP.3系.
- 该研究于2024年9月9日结束,预计结果将于2026年公布.
结论:
- 该研究将为最新的Novavax和Pfizer-BioNTechCOVID-19疫苗配方提供关键的真实世界VE数据.
- 研究结果将支持针对COVID-19疫苗接种策略的基于证据的建议.
- 这项研究对于了解针对当前和未来SARS-CoV-2变种的疫苗性能至关重要.
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