A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine.
A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine.
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DOI：
10.1016/j.vaccine.2021.02.007
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发表时间：
2021-05-12
期刊：
影响因子：
5.5
通讯作者：
mRNA-1273 Study Group
中科院分区：
文献类型：
--
作者：
Chu L;McPhee R;Huang W;Bennett H;Pajon R;Nestorova B;Leav B;mRNA-1273 Study Group
为防止严重急性呼吸综合征冠状病毒2 （SARS-CoV-2）在全球传播，迫切需要疫苗。我们评估了候选疫苗mRNA-1273的安全性和免疫原性，该mrna编码SARS-CoV-2的预灌注稳定刺突蛋白。这项2期随机、观察者盲、安慰剂对照试验在美国8个地点进行，对象为年龄≥18岁、无已知SARS-CoV-2感染史或风险、此前未接受过研究性CoV疫苗或治疗的健康成人。参与者被分为两个年龄组（≥18-<55岁和≥55岁），并被随机分配（1:1:1）至50或100µg mRNA-1273，或安慰剂作为两次肌肉注射间隔28天。主要结局是通过抗sars - cov -2刺突结合抗体水平（bAb）评估安全性、反应原性和免疫原性。次要终点是通过SARS-CoV-2中和抗体（nAb）反应评估免疫原性。在2020年5月29日至7月8日期间，600名参与者被随机分组，每个年龄组300人。在两个年龄组中，最常见的不良反应是每次接种疫苗后注射部位疼痛、头痛和疲劳。一个被现场研究者认为不相关的严重不良事件发生在接种疫苗后33天。mRNA-1273在接种后28天诱导的bAb和nAb中，100µg剂量的aba和nAb高于50µg剂量；接种疫苗后，这种差异不那么明显。结合抗体和nAb在第二次接种后14天（第43天）大幅增加，超过恢复期血清的水平，并在第57天保持升高。在18岁及以上的受试者中，接种mRNA-1273疫苗导致了对SARS-CoV-2的显著免疫应答，具有可接受的安全性，证实了50µg和100µg mRNA-1273作为两种剂量方案的安全性和免疫原性。ClinicalTrials.gov;NCT04405076。
Vaccines are urgently needed to prevent the global spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We assessed the safety and immunogenicity of vaccine candidate mRNA-1273, encoding the prefusion-stabilized spike protein of SARS-CoV-2. This phase 2, randomized, observer-blind, placebo-controlled trial was conducted at 8 sites in the USA, in healthy adults aged ≥18 years with no known history or risk of SARS-CoV-2 infection, and had not previously received an investigational CoV vaccine or treatment. Participants were stratified into two age cohorts (≥18-<55 and ≥55) and were randomly assigned (1:1:1) to either 50 or 100 µg of mRNA-1273, or placebo administered as two intramuscular injections 28 days apart. The primary outcomes were safety, reactogenicity, and immunogenicity assessed by anti-SARS-CoV-2-spike binding antibody level (bAb). Secondary outcome was immunogenicity assessed by SARS-CoV-2 neutralizing antibody (nAb) response. Between 29 May and 8 July 2020, 600 participants were randomized, 300 per age cohort. The most common solicited adverse reactions were pain at injection site, headache, and fatigue following each vaccination in both age cohorts. One serious adverse event deemed unrelated by the site investigator occurred 33 days post-vaccination one. mRNA-1273 induced bAb and nAb by 28 days post-vaccination one that were higher at the 100 µg dose relative to the 50 µg dose; this difference was less apparent post-vaccination two. Binding antibodies and nAb increased substantially by 14 days following the second vaccination (day 43) to levels exceeding those of convalescent sera and remained elevated through day 57. Vaccination with mRNA-1273 resulted in significant immune responses to SARS-CoV-2 in participants 18 years and older, with an acceptable safety profile, confirming the safety and immunogenicity of 50 and 100 µg mRNA-1273 given as a 2 dose-regimen. ClinicalTrials.gov; NCT04405076.
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BNT162B2 mRNA COVID-19疫苗的安全性和功效。
DOI：
10.1056/nejmoa2034577
发表时间：
2020-12-31
期刊：
The New England journal of medicine
影响因子：
--
作者：
Polack FP;Thomas SJ;Kitchin N;Absalon J;Gurtman A;Lockhart S;Perez JL;Pérez Marc G;Moreira ED;Zerbini C;Bailey R;Swanson KA;Roychoudhury S;Koury K;Li P;Kalina WV;Cooper D;Frenck RW Jr;Hammitt LL;Türeci Ö;Nell H;Schaefer A;Ünal S;Tresnan DB;Mather S;Dormitzer PR;Şahin U;Jansen KU;Gruber WC;C4591001 Clinical Trial Group
通讯作者：
C4591001 Clinical Trial Group
影响因子：
28.3
作者：
Gorbalenya, Alexander E.;Baker, Susan C.;Ziebuhr, John
通讯作者：
Ziebuhr, John
影响因子：
120.7
作者：
Li, Ling;Zhang, Wei;Liu, Zhong
通讯作者：
Liu, Zhong
DOI：
10.1016/s0140-6736(20)32137-1
发表时间：
2020-11-14
期刊：
Lancet (London, England)
影响因子：
--
作者：
Poland GA;Ovsyannikova IG;Kennedy RB
通讯作者：
Kennedy RB
影响因子：
9
作者：
Ciabattini A;Garagnani P;Santoro F;Rappuoli R;Franceschi C;Medaglini D
通讯作者：
Medaglini D