小柯机器人

美国辉瑞公司Judith Absalon等研究人员报道了COVID-19 RNA疫苗BNT162b1在成年人中的1/2期临床研究结果。这一研究成果于2020年8月12日在线发表在《自然》上。

研究人员报告了一项正在进行的安慰剂对照、观察者盲目剂量递增研究的可用安全性、耐受性和免疫原性数据，研究对象是45位18至55岁的健康成年人，随机接受2剂，间隔21天，每次10µg 、30µg或100µg的BNT162b1，这是一种脂质纳米颗粒配制的、经核苷修饰的mRNA疫苗，其编码三聚体SARS-CoV-2突刺糖蛋白受体结合结构域（RBD）。局部反应和全身事件是剂量依赖性的，通常是轻度至中度并短暂的。

与30μg剂量相比，由于单反应后反应原性增强且缺乏明显增加的免疫原性，因此未进行100μg的第二次疫苗接种。血清中的RBD结合IgG浓度和SARS-CoV-2中和效价随剂量水平和第二剂后增加。在SARS-CoV-2 PCR阳性后至少14天，几何平均中和滴度达到了一组COVID-19恢复期人血清的1.9-4.6倍。这些结果支持对该mRNA疫苗候选物的进一步评估。

附：英文原文

Title: Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults

Author: Mark J. Mulligan, Kirsten E. Lyke, Nicholas Kitchin, Judith Absalon, Alejandra Gurtman, Stephen Lockhart, Kathleen Neuzil, Vanessa Raabe, Ruth Bailey, Kena A. Swanson, Ping Li, Kenneth Koury, Warren Kalina, David Cooper, Camila Fontes-Garfias, Pei-Yong Shi, zlem Treci, Kristin R. Tompkins, Edward E. Walsh, Robert Frenck, Ann R. Falsey, Philip R. Dormitzer, William C. Gruber, Uur ahin, Kathrin U. Jansen

Issue&Volume: 2020-08-12

Abstract:  We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults, 18 to 55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 μg, 30 μg, or 100 μg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD). Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 μg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 convalescent human sera at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. (ClinicalTrials.gov identifier: NCT04368728).

DOI: 10.1038/s41586-020-2639-4

Source: https://www.nature.com/articles/s41586-020-2639-4

Nature：《自然》，创刊于1869年。隶属于施普林格·自然出版集团，最新IF：69.504
官方网址：http://www.nature.com/
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