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中和抗体检测应用于新型冠状病毒mRNA疫苗效力分析
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作者 吴小红 赵丹华 +4 位作者 所玥 彭沁华 王红玉 刘欣玉 李玉华 《药学研究》 CAS 2023年第11期896-901,共6页
目的 通过对新型冠状病毒(2019 novel coronavirus, 2019-nCoV)mRNA疫苗(新冠mRNA疫苗)免疫小鼠后产生的中和抗体进行检测,探索中和抗体检测法应用于mRNA疫苗体内效力评价的可行性。方法 采用6~8周BALB/c小鼠进行后肢肌肉免疫,检测不同... 目的 通过对新型冠状病毒(2019 novel coronavirus, 2019-nCoV)mRNA疫苗(新冠mRNA疫苗)免疫小鼠后产生的中和抗体进行检测,探索中和抗体检测法应用于mRNA疫苗体内效力评价的可行性。方法 采用6~8周BALB/c小鼠进行后肢肌肉免疫,检测不同免疫剂量和不同免疫程序的中和抗体滴度。并对8家企业生产的新冠mRNA疫苗免疫的小鼠血清进行中和抗体和IgG抗体检测。结果 2、5、10μg不同剂量mRNA疫苗按照不同免疫程序免疫小鼠后中和抗体检测结果显示,抗体阳转率均为100%,中和抗体反应有明显的剂量-效应关系。2针间隔14 d加强免疫组抗体滴度显著高于间隔7 d加强免疫组及1针组(F=57.13,P<0.001)。2μg剂量间隔7 d加强免疫和间隔14 d加强免疫产生的中和抗体几何平均滴度(geometric mean titer, GMT)分别为218和468,差异有统计学意义(t=3.40,P=0.003);5μg剂量间隔7 d加强免疫和间隔14 d加强免疫产生的中和抗体GMT分别为499和1 436,差异有统计学意义(t=3.62,P=0.002);10μg剂量间隔7 d加强免疫和间隔14 d加强免疫产生的中和抗体GMT分别为608和1 909,差异有统计学意义(t=3.23,P=0.005)。国内8家企业生产的新冠mRNA疫苗免疫小鼠后均可产生高滴度的IgG抗体(104.5~107.5)和中和抗体(102.6~104.8),效力测定结果均符合企业质量标准。各企业生产的mRNA疫苗的中和抗体滴度结果差异有统计学意义(F=70.03,P<0.001)。结论 小鼠免疫后中和抗体检测可用于mRNA疫苗的体内效力评价。 展开更多
关键词 新型冠状病毒 mrna疫苗 中和抗体 IGG抗体 效力
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COVID-19 vaccination and myocarditis: A review of current literature
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作者 Kartik Dhaduk Jagjit Khosla +5 位作者 Muzna Hussain Vrunda Mangaroliya Shaylika Chauhan Kumar Ashish Rahul Gupta Suman Pal 《World Journal of Virology》 2022年第4期170-175,共6页
Vaccination for coronavirus disease 2019(COVID-19)is a critical strategy in controlling the current pandemic of severe acute respiratory syndrome coronavirus-2(SARS-CoV-2).After widespread COVID-19 vaccine implementat... Vaccination for coronavirus disease 2019(COVID-19)is a critical strategy in controlling the current pandemic of severe acute respiratory syndrome coronavirus-2(SARS-CoV-2).After widespread COVID-19 vaccine implementation,isolated case reports about myocarditis as a potential adverse reaction started coming.As of November 12,2021,Centers for Disease Control and Prevention(CDC)has reported 1793 cases of myocarditis or pericarditis among young people with age 12-29 years,most cases have been reported in the male adolescent age group after the second dose of mRNA COVID-19 vaccines.It is very important to monitor the safety standards and adverse reactions of vaccines to effectively implement the vaccination policies.The CDC and the United States Food and Drug Administration actively monitor vaccine-associated adverse reactions a well-known platform such as Vaccine Adverse Event Reporting System.CDC continues to recommend COVID-19 vaccines and booster doses for eligible individuals(age limit according to the type of vaccine)after careful consideration from risk-benefit assessment and favorable outcomes from vaccination.Mechanisms behind COVID-19 vaccine-induced myocarditis are not clear yet but several possibilities such as molecular mimicry between the spike protein of SARS-CoV-2 and self-antigens,immune response to mRNA,and activation of host immunological system,trigger of the pre-existing dysregulated immunological system have been documented in the literature.Overall,data suggests a good prognosis,especially in young patients.In this review article,we cover currently available data on COVID-19 vaccine-related myocarditis incidence,concerns,possible mechanisms of myocarditis,current treatment,and outcome trends,risk vs benefit assessment of COVID-19 vaccination in this current pandemic. 展开更多
关键词 Coronavirus disease 2019 vaccine MYOCARDITIS mrna vaccine Severe acute respiratory syndrome coronavirus-2 vaccine complications Risk assessment
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Immunogenicity and reactogenicity of heterologous immunization schedules with COVID-19 vaccines:a systematic review and network meta-analysis
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作者 Pei Li Weiwei Wang +7 位作者 Yiming Tao Xiaoyu Tan Yujing Li Yinjun Mao Le Gao Lei Feng Siyan Zhan Feng Sun 《Chinese Medical Journal》 SCIE CAS CSCD 2023年第1期24-33,共10页
Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules... Background:Data on the immunogenicity and safety of heterologous immunization schedules are inconsistent.This study aimed to evaluate the immunogenicity and safety of homologous and heterologous immunization schedules.Methods:Multiple databases with relevant studies were searched with an end date of October 31,2021,and a website including a series of Coronavirus disease 2019 studies was examined for studies before March 31,2022.Randomized controlled trials(RCTs)that compared different heterologous and homologous regimens among adults that reported immunogenicity and safety outcomes were reviewed.Primary outcomes included neutralizing antibodies against the original strain and serious adverse events(SAEs).A network meta-analysis(NMA)was conducted using a random-effects model.Results:In all,11 RCTs were included in the systematic review,and nine were ultimately included in the NMA.Among participants who received two doses of CoronaVac,another dose of mRNA or a non-replicating viral vector vaccine resulted in a significantly higher level of neutralizing antibody than a third CoronaVac 600 sino unit(SU);a dose of BNT162b2 induced the highest geometric mean ratio(GMR)of 15.24,95%confidence interval[CI]:9.53–24.39.Following one dose of BNT162b2 vaccination,a dose of mRNA-1273 generated a significantly higher level of neutralizing antibody than BNT162b2 alone(GMR=1.32;95%CI:1.06–1.64),NVX-CoV2373(GMR=1.60;95%CI:1.16–2.21),or ChAdOx1(GMR=1.80;95%CI:1.25–2.59).Following one dose of ChAdOx1,a dose of mRNA-1273 was also more effective for improving antibody levels than ChAdOx1(GMR=11.09;95%CI:8.36–14.71)or NVX-CoV2373(GMR=2.87;95%CI:1.08–3.91).No significant difference in the risk for SAEs was found in any comparisons.Conclusions:Relative to vaccination with two doses of CoronaVac,a dose of BNT162b2 as a booster substantially enhances immunogenicity reactions and has a relatively acceptable risk for SAEs relative to other vaccines.For primary vaccination,schedules including mRNA vaccines induce a greater immune response.However,the comparatively higher risk for local and systemic adverse events introduced by mRNA vaccines should be noted.Registration:PROSPERO;https://www.crd.york.ac.uk/PROSPERO/;No.CRD42021278149. 展开更多
关键词 COVID-19 2019-ncov vaccine mrna-1273 BNT162 vaccine vaccinATION Immunization schedule Antibodies Neutralizing HETEROLOGOUS IMMUNOGENICITY Network meta-analysis
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核酸疫苗研发态势与发展建议 被引量:8
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作者 李爱花 杨雪梅 +2 位作者 孙轶楠 苑亚坤 杨俊涛 《中国工程科学》 CSCD 北大核心 2021年第4期153-161,共9页
应对新型冠状病毒肺炎(COVID-19)疫情防控的迫切需求,核酸疫苗以其快速高效的优点得到了疫苗研发领域的高度重视,特别是信使核糖核酸(mRNA)疫苗的研发进程显著加快,首次获批上市并在人体中使用。本文从核酸疫苗及相关技术概念、研发轨... 应对新型冠状病毒肺炎(COVID-19)疫情防控的迫切需求,核酸疫苗以其快速高效的优点得到了疫苗研发领域的高度重视,特别是信使核糖核酸(mRNA)疫苗的研发进程显著加快,首次获批上市并在人体中使用。本文从核酸疫苗及相关技术概念、研发轨迹与发展趋势等方面总结梳理核酸疫苗的研发态势,辨识核酸疫苗特征,分析COVID-19疫情对mRNA疫苗研究的促进作用,梳理核酸疫苗拓展应用的主要领域,针对可能存在的技术性、安全性问题开展深入讨论。研究建议,从改良目的基因表达、完善递送系统、提高免疫应答、增强mRNA稳定性及易存性等方面着手,着力开展核酸疫苗的关键技术开发;严格监管核酸疫苗的安全性和有效性;引导利益相关方对具有安全性风险、可能对肿瘤与传染病防控带来颠覆性影响的mRNA疫苗技术开展改进研究,注重技术研发的前瞻布局并促进应用转化。 展开更多
关键词 核酸疫苗 脱氧核糖核酸(DNA)疫苗 核糖核酸(RNA)疫苗 信使核糖核酸(mrna)疫苗 新型冠状病毒肺炎 肿瘤
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mRNA疫苗的原理、研究现状和展望 被引量:2
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作者 胡佳欣 章晓联 《武汉大学学报(医学版)》 CAS 2023年第9期1033-1045,共13页
近些年新型冠状病毒肺炎、流感和结核病等传染病给全球带来了相当大的社会和经济负担。疫苗接种是控制其传播,挽救生命和保护人口健康的最有效和最经济的干预措施。近年来,mRNA疫苗由于其研制周期短、易于产业化、生产工艺简单、易对新... 近些年新型冠状病毒肺炎、流感和结核病等传染病给全球带来了相当大的社会和经济负担。疫苗接种是控制其传播,挽救生命和保护人口健康的最有效和最经济的干预措施。近年来,mRNA疫苗由于其研制周期短、易于产业化、生产工艺简单、易对新变体作出反应、能更好诱导免疫反应的特点,引起了广泛的关注和研究。本篇综述概述了mRNA疫苗的分类和运载系统,总结了mRNA通过不同途径和通路发挥作用的机制、不同mRNA疫苗的研究现状,并简要讨论了开发针对不同疾病的mRNA疫苗的当前挑战和未来方向。 展开更多
关键词 mrna疫苗 新型冠状病毒肺炎 结核病 癌症
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COVID-19 Pandemic: Its Origin, Implications and Treatments 被引量:2
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作者 Peter K. Law 《Open Journal of Regenerative Medicine》 2020年第2期43-64,共22页
This is a succinct and current review of pertinent literature to guide developing serum therapy as an emergent treatment to save human lives at times of natural or genetically engineered viral/bacterial pandemics. The... This is a succinct and current review of pertinent literature to guide developing serum therapy as an emergent treatment to save human lives at times of natural or genetically engineered viral/bacterial pandemics. The origin of 2019-nCoV and implications of COVID-19 are discussed using direct quotes of published scientific literature to avoid misinterpretation on this very important event that has caused great loss of human lives and international social economy. It is the goal of this review to warn against and to correct international misunderstanding created by deliberate falsification of scientific documentations and events. This misunderstanding may lead to further destruction of life, economy, and political relations. People should not be blind-sighted when making life decisions. 展开更多
关键词 2019-ncov COVID-19 Serum Therapy Pandemics EPIDEMICS Convalescent Plasma CORONAVIRUS vaccine Bacteria Mutation Biologic Warfare Weapons
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mRNA-based modalities for infectious disease management 被引量:1
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作者 Mengjie Zhang Abid Hussain +3 位作者 Haiyin Yang Jinchao Zhang Xing-Jie Liang Yuanyu Huang 《Nano Research》 SCIE EI CSCD 2023年第1期672-691,共20页
The novel coronavirus disease 2019(COVID-19)is still rampant all over the world,causing incalculable losses to the world.Major pharmaceutical organizations around the globe are focusing on vaccine research and drug de... The novel coronavirus disease 2019(COVID-19)is still rampant all over the world,causing incalculable losses to the world.Major pharmaceutical organizations around the globe are focusing on vaccine research and drug development to prevent further damage caused by the pandemic.The messenger RNA(mRNA)technology has got ample of attention after the success of the two very effective mRNA vaccines during the recent pandemic of COVID-19.mRNA vaccine has been promoted to the core stage of pharmaceutical industry,and the rapid development of mRNA technology has exceeded expectations.Beyond COVID-19,the mRNA vaccine has been tested for various infectious diseases and undergoing clinical trials.Due to the ability of constant mutation,the viral infections demand abrupt responses and immediate production,and therefore mRNA-based technology offers best answers to sudden outbreaks.The need for mRNA-based vaccine became more obvious due to the recent emergence of new Omicron variant.In this review,we summarized the unique properties of mRNA-based vaccines for infectious diseases,delivery technologies,discussed current challenges,and highlighted the prospects of this promising technology in the future.We also discussed various clinical studies as well preclinical studies conducted on mRNA therapeutics for diverse infectious diseases. 展开更多
关键词 messenger RNA(mrna)vaccine lipid-nanoparticle infectious disease drug delivery coronavirus disease 2019(COVID-19) virus
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新型冠状病毒mRNA疫苗研发进展 被引量:11
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作者 张琳 李燕 安志杰 《中国疫苗和免疫》 北大核心 2020年第3期349-356,共8页
2019冠状病毒病已进入全球大流行阶段,成为全球严重的公共卫生问题之一,给各个国家和地区带来沉重的社会经济负担,迫切需要有效的疫苗来应对。目前尚无可用的新型冠状病毒疫苗,许多国家正在积极进行新型冠状病毒疫苗的研发,本文实时追... 2019冠状病毒病已进入全球大流行阶段,成为全球严重的公共卫生问题之一,给各个国家和地区带来沉重的社会经济负担,迫切需要有效的疫苗来应对。目前尚无可用的新型冠状病毒疫苗,许多国家正在积极进行新型冠状病毒疫苗的研发,本文实时追踪和综述了新型冠状病毒mRNA疫苗的研发进展。 展开更多
关键词 新型冠状病毒 2019冠状病毒病 mrna疫苗 进展
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mRNA疫苗及其作用机制的研究进展 被引量:10
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作者 孟子延 马丹婧(综述) +1 位作者 高雪 李琦涵(审校) 《中国生物制品学杂志》 CAS CSCD 北大核心 2021年第6期740-744,共5页
目前,重症急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)引起的新型冠状病毒病(Corona Virus Disease 2019,COVID-19)仍在全球迅速蔓延,给人类生活带来了巨大的健康隐患和经济负担,接种疫苗是... 目前,重症急性呼吸综合征冠状病毒2(severe acute respiratory syndrome coronavirus 2,SARS-CoV-2)引起的新型冠状病毒病(Corona Virus Disease 2019,COVID-19)仍在全球迅速蔓延,给人类生活带来了巨大的健康隐患和经济负担,接种疫苗是预防和控制该病毒传播的重要途径。mRNA疫苗是将含有编码抗原蛋白的mRNA导入人体,直接进行翻译,形成相应的抗原蛋白,从而诱导机体产生特异性免疫应答,达到预防免疫的作用。mRNA疫苗是继灭活疫苗、减毒活疫苗、亚单位疫苗和病毒载体疫苗后的第三代疫苗,具有针对病原体变异反应速度快、生产工艺简单、易规模化扩大等特点。本文就mRNA疫苗的免疫学特性、分子设计、递送系统、安全性的研究进展及其相应机制作一综述。 展开更多
关键词 mrna疫苗 重症急性呼吸综合征冠状病毒2 新型冠状病毒病 安全性
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mRNA技术及其在传染病疫苗研发中的应用 被引量:8
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作者 柯尊阳 王宇 +1 位作者 李忠明 于继云 《中华微生物学和免疫学杂志》 CAS CSCD 北大核心 2020年第9期661-667,共7页
mRNA疫苗技术是近年逐渐发展起来的疫苗新技术之一,其在稳定性、高效投递等方面的技术日趋成熟。mRNA疫苗在细胞内表达抗原,通过刺激免疫系统产生B、T细胞免疫应答等多种效应机制,可达到预防传染病的作用。同时由于其是全合成制备,生产... mRNA疫苗技术是近年逐渐发展起来的疫苗新技术之一,其在稳定性、高效投递等方面的技术日趋成熟。mRNA疫苗在细胞内表达抗原,通过刺激免疫系统产生B、T细胞免疫应答等多种效应机制,可达到预防传染病的作用。同时由于其是全合成制备,生产工艺简单,具有快速应对诸如新型冠状病毒感染等突发传染病疫情的潜力。为了解传染病mRNA疫苗的开发与研究现状,本文重点对mRNA疫苗的结构特点、优势和挑战以及应用于传染病疫苗研究的现状进行了综述,为新型冠状病毒等传染病mRNA疫苗的研发提供一定借鉴。 展开更多
关键词 mrna技术 传染病 新型冠状病毒mrna疫苗 临床前研究 临床试验
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