文献检索文档翻译深度研究
Suppr Zotero 插件Zotero 插件
邀请有礼套餐&价格历史记录

新学期,新优惠

限时优惠:9月1日-9月22日

30天高级会员仅需29元

1天体验卡首发特惠仅需5.99元

了解详情
不再提醒
插件&应用
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
高级版
套餐订阅购买积分包
AI 工具
文献检索文档翻译深度研究
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2025

《新型冠状病毒 SARS-CoV-2 BNT162b1 mRNA 疫苗在中国年轻和老年成年人中的安全性和免疫原性:一项随机、安慰剂对照、双盲的 1 期研究》。

Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study.

机构信息

NHC Key Laboratory of Enteric Pathogenic Microbiology, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.

Fosun Pharma, Boston, MA, USA.

出版信息

Nat Med. 2021 Jun;27(6):1062-1070. doi: 10.1038/s41591-021-01330-9. Epub 2021 Apr 22.


DOI:10.1038/s41591-021-01330-9
PMID:33888900
Abstract

An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Here, we assess the preliminary safety, tolerability and immunogenicity data from an ongoing single-center (in Jiangsu province, China), parallel-group, double-blind phase 1 trial of the vaccine candidate BNT162b1 in 144 healthy SARS-CoV-2-naive Chinese participants. These participants are randomized 1:1:1 to receive prime and boost vaccinations of 10 µg or 30 µg BNT162b1 or placebo, given 21 d apart, with equal allocation of younger (aged 18-55 years) and older adults (aged 65-85 years) to each treatment group (ChiCTR2000034825). BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) and is one of several messenger RNA-based vaccine candidates under clinical investigation. Local reactions and systemic events were generally dose dependent, transient and mild to moderate. Fever was the only grade 3 adverse event. BNT162b1 induced robust interferon-γ T cell responses to a peptide pool including the RBD in both younger and older Chinese adults, and geometric mean neutralizing titers reached 2.1-fold (for younger participants) and 1.3-fold (for the older participants) that of a panel of COVID-19 convalescent human sera obtained at least 14 d after positive SARS-CoV-2 polymerase chain reaction test. In summary, BNT162b1 has an acceptable safety profile and produces high levels of humoral and T cell responses in an Asian population.

摘要

需要一种有效的疫苗来结束严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)大流行。在这里,我们评估了正在进行的一项在中国江苏省进行的单中心、平行组、双盲 1 期试验中疫苗候选物 BNT162b1 的初步安全性、耐受性和免疫原性数据,该试验纳入了 144 名 SARS-CoV-2 未感染的健康中国参与者。这些参与者按照 1:1:1 的比例随机分为 3 组,分别接受 10µg 或 30µg BNT162b1 或安慰剂的基础免疫和加强免疫,间隔 21 天,每组中年轻(18-55 岁)和老年(65-85 岁)参与者的分配比例相等(ChiCTR2000034825)。BNT162b1 编码 SARS-CoV-2 刺突糖蛋白受体结合域(RBD),是几种正在临床研究中的信使 RNA 疫苗候选物之一。局部反应和全身事件通常与剂量有关,是短暂的,且为轻度至中度。发热是唯一的 3 级不良事件。BNT162b1 在年轻和老年中国成年人中诱导了针对 RBD 肽池的强烈干扰素-γ T 细胞反应,几何平均中和滴度分别比 COVID-19 恢复期人类血清的 2.1 倍(年轻参与者)和 1.3 倍(老年参与者)高,这些血清是在 SARS-CoV-2 聚合酶链反应检测呈阳性至少 14 天后获得的。总之,BNT162b1 在亚洲人群中具有可接受的安全性,并产生高水平的体液和 T 细胞反应。

相似文献

[1]
Safety and immunogenicity of the SARS-CoV-2 BNT162b1 mRNA vaccine in younger and older Chinese adults: a randomized, placebo-controlled, double-blind phase 1 study.

Nat Med. 2021-6

[2]
Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates.

N Engl J Med. 2020-10-14

[3]
Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial.

Lancet Microbe. 2022-3

[4]
BNT162b vaccines protect rhesus macaques from SARS-CoV-2.

Nature. 2021-4

[5]
Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials.

Lancet Infect Dis. 2021-8

[6]
Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults.

Nature. 2020-8-12

[7]
Safety and immunogenicity of COReNAPCIN, a SARS-CoV-2 mRNA vaccine, as a fourth heterologous booster in healthy Iranian adults: A double-blind, randomized, placebo-controlled, phase 1 clinical trial with a six-month follow-up.

Int Immunopharmacol. 2024-6-15

[8]
A single dose of self-transcribing and replicating RNA-based SARS-CoV-2 vaccine produces protective adaptive immunity in mice.

Mol Ther. 2021-6-2

[9]
COVID-19 vaccine BNT162b1 elicits human antibody and T1 T cell responses.

Nature. 2020-9-30

[10]
Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial.

PLoS Med. 2021-10

引用本文的文献

[1]
Development of lyophilized mRNA-LNPs with high stability and transfection efficiency in specific cells and tissues.

Regen Biomater. 2025-4-10

[2]
Nanotechnology-based mRNA vaccines.

Nat Rev Methods Primers. 2023

[3]
Comparative immunologic profiling of mRNA and protein-conjugated vaccines: acute inflammatory responses and anti-PEG antibody production.

Anim Cells Syst (Seoul). 2025-6-10

[4]
Safety and immunogenicity of a modified COVID-19 mRNA vaccine, SYS6006, as a fourth-dose booster following three doses of inactivated vaccines in healthy adults: an open-labeled Phase 1 trial.

Life Metab. 2023-5-10

[5]
Global research on RNA vaccines for COVID-19 from 2019 to 2023: a bibliometric analysis.

Front Immunol. 2024

[6]
Safety and reactogenicity of the BNT162b2 COVID-19 vaccine: Development, post-marketing surveillance, and real-world data.

Hum Vaccin Immunother. 2024-12-31

[7]
Mathematical Optimization Strategy for Effectiveness Profile Estimation in Two-Dose Vaccines and Its Use in Designing Improved Vaccination Strategies Focused on Pandemic Containment.

Vaccines (Basel). 2024-1-12

[8]
Is There a Causal Link Between Acute Myocarditis and COVID-19 Vaccination: An Umbrella Review of Published Systematic Reviews and Meta-Analyses.

Clin Med Insights Cardiol. 2024-1-18

[9]
Safety and immunogenicity of primary vaccination with a SARS-CoV-2 mRNA vaccine (SYS6006) in Chinese participants aged 18 years or more: Two randomized, observer-blinded, placebo-controlled and dose-escalation phase 1 clinical trials.

Hum Vaccin Immunother. 2023-12-15

[10]
Employment of a high throughput functional assay to define the critical factors that influence vaccine induced cross-variant neutralizing antibodies for SARS-CoV-2.

Sci Rep. 2023-12-9

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

推荐工具

医学文档翻译智能文献检索