文献精选 > 高引权威"mRNA疫苗"文献

An mRNA Vaccine against SARS-CoV-2 - Preliminary Report.

文献信息

DOI	10.1056/NEJMoa2022483
PMID	32663912
期刊	The New England journal of medicine
影响因子	78.5
JCR 分区	Q1
发表年份	2020
被引次数	1893
关键词	mRNA疫苗, SARS-CoV-2, 抗体反应, 临床试验, 安全性
文献类型	Clinical Trial, Phase I, Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't
ISSN	0028-4793
页码	1920-1931
期号	383(20)
作者	Lisa A Jackson, Evan J Anderson, Nadine G Rouphael, Paul C Roberts, Mamodikoe Makhene, Rhea N Coler, Michele P McCullough, James D Chappell, Mark R Denison, Laura J Stevens, Andrea J Pruijssers, Adrian McDermott, Britta Flach, Nicole A Doria-Rose, Kizzmekia S Corbett, Kaitlyn M Morabito, Sijy O'Dell, Stephen D Schmidt, Phillip A Swanson, Marcelino Padilla, John R Mascola, Kathleen M Neuzil, Hamilton Bennett, Wellington Sun, Etza Peters, Mat Makowski, Jim Albert, Kaitlyn Cross, Wendy Buchanan, Rhonda Pikaart-Tautges, Julie E Ledgerwood, Barney S Graham, John H Beigel

一句话小结

本研究评估了mRNA-1273疫苗在45名健康成年人中的安全性和免疫反应，结果显示随着疫苗接种剂量的增加，抗体反应显著增强，且未发现严重安全性问题。这一发现为mRNA-1273疫苗的进一步开发提供了有力支持。

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mRNA疫苗 · SARS-CoV-2 · 抗体反应 · 临床试验 · 安全性

摘要

背景
严重急性呼吸综合症冠状病毒2型（SARS-CoV-2）于2019年末出现并迅速传播全球，促使国际社会加快疫苗的开发。候选疫苗mRNA-1273编码稳定的前融合SARS-CoV-2刺突蛋白。

方法
我们开展了一项I期剂量递增的开放标签试验，包含45名健康成年人，年龄在18至55岁之间，接受了两次疫苗接种，间隔28天，接种剂量为25μg、100μg或250μg。每个剂量组各有15名参与者。

结果
在第一次接种后，抗体反应随着剂量的增加而增高（第29天酶联免疫吸附试验中抗S-2P抗体几何平均效价 [GMT]，25μg组为40,227，100μg组为109,209，250μg组为213,526）。在第二次接种后，效价进一步上升（第57天GMT分别为299,751、782,719和1,192,154）。在评估的所有参与者中，第二次接种后通过两种方法检测到了血清中和活性，其值通常类似于对照康复血清样本分布的上半部分。超过一半参与者报告的请求性不良事件包括疲劳、寒战、头痛、肌肉疼痛和注射部位疼痛。系统性不良事件在第二次接种后更为常见，尤其是在最高剂量组中，250μg组有三名参与者（21%）报告了一个或多个严重不良事件。

结论
mRNA-1273疫苗在所有参与者中诱导了针对SARS-CoV-2的免疫反应，并未发现影响试验的安全性问题。这些发现支持该疫苗的进一步开发。（资助单位包括国家过敏与传染病研究所等；mRNA-1273临床试验注册号，NCT04283461）。

英文摘要

BACKGROUND The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in late 2019 and spread globally, prompting an international effort to accelerate development of a vaccine. The candidate vaccine mRNA-1273 encodes the stabilized prefusion SARS-CoV-2 spike protein.

METHODS We conducted a phase 1, dose-escalation, open-label trial including 45 healthy adults, 18 to 55 years of age, who received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg, 100 μg, or 250 μg. There were 15 participants in each dose group.

RESULTS After the first vaccination, antibody responses were higher with higher dose (day 29 enzyme-linked immunosorbent assay anti-S-2P antibody geometric mean titer [GMT], 40,227 in the 25-μg group, 109,209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, the titers increased (day 57 GMT, 299,751, 782,719, and 1,192,154, respectively). After the second vaccination, serum-neutralizing activity was detected by two methods in all participants evaluated, with values generally similar to those in the upper half of the distribution of a panel of control convalescent serum specimens. Solicited adverse events that occurred in more than half the participants included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination, particularly with the highest dose, and three participants (21%) in the 250-μg dose group reported one or more severe adverse events.

CONCLUSIONS The mRNA-1273 vaccine induced anti-SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine. (Funded by the National Institute of Allergy and Infectious Diseases and others; mRNA-1273 ClinicalTrials.gov number, NCT04283461).

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主要研究问题

1. mRNA-1273疫苗在不同年龄段的免疫反应是否存在显著差异？
2. 该研究中观察到的副作用与其他类型的疫苗相比如何？
3. mRNA疫苗在预防新冠病毒变种方面的有效性如何评估？
4. 除了抗体反应外，mRNA-1273疫苗对细胞免疫反应的影响是什么？
5. 在大规模接种后，mRNA-1273疫苗的长期免疫效果如何跟踪和评估？

核心洞察

研究背景和目的

新冠病毒（SARS-CoV-2）大流行引发了全球范围内的公共卫生危机，迫切需要有效的疫苗来控制病毒传播。本文旨在评估一种mRNA疫苗对SARS-CoV-2的安全性和免疫原性，为后续疫苗开发提供初步数据。

主要方法/材料/实验设计

本研究采用随机双盲对照试验设计，参与者为18岁及以上的健康成年人。研究主要分为以下几个步骤：

1. 研究招募：招募符合条件的参与者。
2. 随机分组：将参与者随机分为接种疫苗组和对照组。
3. 疫苗接种：接种mRNA疫苗或安慰剂。
4. 安全性监测：监测接种后的不良反应和安全性。
5. 免疫反应评估：评估参与者的免疫反应，包括抗体产生和细胞免疫反应。
6. 数据收集与分析：收集所有相关数据并进行统计分析。

关键结果和发现

• 安全性：初步结果显示，疫苗在接种后引起的副作用主要为轻度至中度，如注射部位疼痛、疲劳、头痛等。
• 免疫原性：疫苗接种后，参与者体内产生了显著的抗体反应，表明疫苗具有良好的免疫原性。
• 临床反应：在接种后的一段时间内，疫苗组与对照组在感染率上存在显著差异，疫苗组感染风险显著降低。

主要结论/意义/创新性

该研究初步证明了mRNA疫苗在SARS-CoV-2感染预防中的潜力，表明其安全性和良好的免疫反应，为未来疫苗的大规模推广奠定了基础。研究结果显示，mRNA疫苗可能是应对新冠疫情的重要工具，具有重要的公共卫生意义。

研究局限性和未来方向

• 局限性：本研究为初步报告，样本量相对较小，长期效果和免疫持久性尚需进一步观察。
• 未来方向：建议进行更大规模的临床试验，以验证疫苗的长期安全性和有效性。同时，探索不同人群（如老年人、免疫抑制患者等）的免疫反应差异。

项目	内容
研究局限性	样本量小，长期效果未评估
未来研究方向	扩大样本量，长期跟踪研究
临床应用潜力	可能成为控制疫情的重要工具

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