Plain Language Summary of a Clinical Trial Evaluating mRNA-1273, Moderna's mRNA-Based COVID-19 Vaccine, in Children 6 Through 11 Years of Age

IF 2.1 4区医学 Q3 VIROLOGY

Future Virology Pub Date : 2023-07-28 DOI:10.2217/fvl-2023-0020

C. Creech, E. Anderson, V. Berthaud, Í. Yildirim, AM Atz, I. M. Baez, D. Finkelstein, P. Pickrell, J. Kirstein, C. Yut, R. Blair, RA Clifford, M. Dunn, JD Campbell, D. Montefiori, JE Tomassini, X. Zhao, W. Deng, H. Zhou, D. Schrempp, K. Hautzinger, B. Girard, K. Slobod, R. McPhee, R. Pajon, R. Das, Jm Miller, S. S. Ghamloush

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Abstract

The PLSP summarizes results from the phase 2/3 KidCOVE trial examining mRNA-1273 (Moderna's COVID-19 vaccine) in children 6 through 11 years of age. This study reviewed results from two parts of the KidCOVE clinical trial: Part 1 of the study was performed to select a dose of mRNA-1273 (50 μg or 100 μg) in children. A 50-μg dose was selected for further evaluation based on minimally unwanted side effects and sufficient antibodies (immune responses) against SARS-CoV-2. Part 2 of the study further evaluated the 50-μg dose of mRNA-1273 and compared it with placebo in children. Two 50-μg doses of mRNA-1273 were well tolerated with no new safety concerns. Two 50-μg doses also produced antibodies (immune responses) similar to those in young adults who received mRNA-1273 (100 μg) in a separate phase 3 study (the COVE trial). Study findings suggest that two 50-μg doses of mRNA-1273 were well-tolerated, and can prevent COVID-19 in children 6 through 11 years of age. Clinical Trial Registration: NCT04796896 ( ClinicalTrials.gov )

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一项评估mRNA-1273 (Moderna基于mrna的COVID-19疫苗)在6至11岁儿童中的临床试验总结

PLSP总结了KidCOVE 2/3期试验在6至11岁儿童中检测mRNA-1273（莫德纳新冠肺炎疫苗）的结果。本研究回顾了KidCOVE临床试验的两个部分的结果：研究的第一部分是在儿童中选择mRNA-1273的剂量（50μg或100μg）。根据最小的不良副作用和足够的抗严重急性呼吸系统综合征冠状病毒2型抗体（免疫反应），选择50μg剂量进行进一步评估。该研究的第2部分进一步评估了50μg剂量的mRNA-1273，并将其与儿童安慰剂进行了比较。两个50μg剂量的mRNA-1273耐受性良好，没有新的安全问题。在一项单独的3期研究（COVE试验）中，两次50μg剂量也产生了与接受mRNA-1273（100μg）的年轻人相似的抗体（免疫反应）。研究结果表明，两种50μg剂量的mRNA-1273耐受性良好，可以预防6至11岁儿童的新冠肺炎。临床试验注册：NCT04796896（ClinicalTrials.gov）

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来源期刊

Future Virology 医学-病毒学

CiteScore

4.00

自引率

3.20%

发文量

审稿时长

6-12 weeks

期刊介绍： Future Virology is a peer-reviewed journal that delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this ever-expanding area of research. It is an interdisciplinary forum for all scientists working in the field today.