随机对照试验显示,推迟3个月的COVID-19 mRNA增强剂疫苗接种没有益处
Wen Shi Lee1, Jennifer Audsley2, Mai-Chi Trieu1,3
1Department of Microbiology and Immunology, Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria, Australia.
The Journal of clinical investigation
|July 11, 2024
概括
在高度接种疫苗的个体中推迟对COVID-19 (冠状病毒疾病2019) 进行双价mRNA增强疫苗接种并没有改善抗体反应或减少感染. 该研究发现,延迟在特有阶段的强化剂量没有益处.
科学领域:
- 免疫学 免疫学 免疫学
- 疫苗学 疫苗学 疫苗学
- 传染性疾病 传染性疾病
背景情况:
- 在流行病阶段,在高度接种疫苗的人群中,关于COVID-19 (冠状病毒疾病2019) 强化疫苗接种的最佳时间存在不确定性.
- 之前对初级疫苗接种的研究表明,较长的时间间隔可以增强免疫力.
- 当前的流行病阶段为助推器定时策略带来了独特的挑战.
研究的目的:
- 评估延迟双价mRNA增强疫苗接种对免疫反应和SARS-CoV-2 (严重急性呼吸系统综合征-冠状病毒-2) 感染的影响.
- 在完全接种疫苗的成年人中,比较立即与3个月延迟的双价值SpikevaxmRNA助推剂.
- 评估中和抗体水平,抗体动力学和疫苗接种计划之间的感染率.
主要方法:
- 一项随机对照试验涉及52名完全接种疫苗的成年人,从2022年11月到2023年8月进行.
- 参与者被分配接受立即或延迟3个月的双价mRNA增强剂疫苗.
- 收集了唾液和血样本,并分析了抗体反应,抗体依赖的细胞活性和感染发生情况.
主要成果:
- 对祖先和Omicron菌株的中和抗体反应在即时和延迟的增强剂组之间是可比的.
- 血和唾液抗体水平 (IgG,IgA),抗体依赖的细胞活性和抗体衰变动力学没有显著差异.
- 在49%的参与者中发生了SARS-CoV-2感染,在随访期间,在两种接种疫苗的手臂中出现了相似的发病率.
结论:
- 在流行病阶段,在免疫前的人群中推迟对COVID-19的双价mRNA增强疫苗接种没有明显的益处.
- 立即的补充疫苗似乎与延迟的计划在维持免疫保护方面同样有效.
- 这些发现为正在进行的COVID-19疫苗接种活动的公共卫生策略提供了信息.
相关概念视频
Vaccinations
Overview
Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
Bioavailability Study Design: Single Versus Multiple Dose Studies
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...
Bioavailability Study Design: Healthy Subjects Versus Patients
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,...
Bioequivalence studies: Biowaivers
In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
Vaccines
Vaccines are among the most effective tools in preventive medicine, designed to prepare the immune system to recognize and combat infectious agents. By introducing antigens—substances that the immune system identifies as foreign—vaccines stimulate an adaptive immune response that leads to immunological memory. This immunological memory enables the body to mount a faster and more effective response upon future exposures to the actual pathogen.Vaccines can be categorized based on the type of...


