在50岁及以上的成年人中,佐剂重组带状疱疹疫苗与COVID-19 mRNA-1273加强疫苗联合使用无免疫干扰或安全问题:一项随机试验

A. Naficy, Adrienne Kuxhausen, P. Pirrotta, B. Leav, Jacqueline Miller, Kate Anteyi, J. Danier, Thomas Breuer, A. Mwakingwe-Omari
{"title":"在50岁及以上的成年人中,佐剂重组带状疱疹疫苗与COVID-19 mRNA-1273加强疫苗联合使用无免疫干扰或安全问题:一项随机试验","authors":"A. Naficy, Adrienne Kuxhausen, P. Pirrotta, B. Leav, Jacqueline Miller, Kate Anteyi, J. Danier, Thomas Breuer, A. Mwakingwe-Omari","doi":"10.1101/2023.03.10.23286967","DOIUrl":null,"url":null,"abstract":"Background: There is growing consensus that COVID-19 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults. Methods: In this phase 3, randomized, open-label study, eligible adults aged [≥]50 years were randomly assigned (1:1) to receive mRNA-1273 (50g) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post RZV1 in both groups. Primary objectives were noninferiority of anti-glycoprotein E and anti-Spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives. Results: 273 participants were randomized to the Seq group, 272 to the Coad group. Protocol-specified non-inferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI], 0.89-1.13) for anti-gE antibodies 1-month post-RZV2, and 1.09 (95% CI 0.90-1.32) for anti-Spike antibodies 1-month post-mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration [≤]2.5 days. Administration site pain and myalgia were the most frequently reported in both groups. Conclusions: Coadministration of mRNA-1273 booster vaccine with RZV in adults aged [≥]50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially (clinicaltrials.gov NCT05047770).","PeriodicalId":10421,"journal":{"name":"Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2023-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"No immunological interference or safety concerns when adjuvanted recombinant zoster vaccine is coadministered with a COVID-19 mRNA-1273 booster vaccine in adults aged 50 years and older: A randomized trial\",\"authors\":\"A. Naficy, Adrienne Kuxhausen, P. Pirrotta, B. Leav, Jacqueline Miller, Kate Anteyi, J. Danier, Thomas Breuer, A. Mwakingwe-Omari\",\"doi\":\"10.1101/2023.03.10.23286967\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background: There is growing consensus that COVID-19 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults. Methods: In this phase 3, randomized, open-label study, eligible adults aged [≥]50 years were randomly assigned (1:1) to receive mRNA-1273 (50g) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post RZV1 in both groups. Primary objectives were noninferiority of anti-glycoprotein E and anti-Spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives. Results: 273 participants were randomized to the Seq group, 272 to the Coad group. Protocol-specified non-inferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI], 0.89-1.13) for anti-gE antibodies 1-month post-RZV2, and 1.09 (95% CI 0.90-1.32) for anti-Spike antibodies 1-month post-mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration [≤]2.5 days. Administration site pain and myalgia were the most frequently reported in both groups. Conclusions: Coadministration of mRNA-1273 booster vaccine with RZV in adults aged [≥]50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially (clinicaltrials.gov NCT05047770).\",\"PeriodicalId\":10421,\"journal\":{\"name\":\"Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-03-12\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1101/2023.03.10.23286967\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1101/2023.03.10.23286967","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

背景:越来越多的共识认为,COVID-19加强疫苗可与其他适龄疫苗共同接种。在现有有限的支持联合接种的数据基础上,特别是与佐剂疫苗联合接种,可以提高成人的疫苗覆盖率。方法:在这项3期随机、开放标签研究中,年龄[≥]50岁的符合条件的成年人被随机分配(1:1)接受mRNA-1273 (50g)加强疫苗接种,并间隔2周(Seq组)或同时(Coad组)接种第一剂重组带状疱疹疫苗(RZV1)。第二剂RZV (RZV2)在两组RZV1后2个月给予。主要目的是与Seq组相比,Coad组的抗糖蛋白E和抗刺突蛋白抗体反应的非劣效性。安全性和进一步的免疫原性评估是次要目标。结果:273名受试者被随机分为Seq组,272名受试者被随机分为Coad组。符合方案规定的非劣效性标准。rzv2后1个月的抗ge抗体校正几何平均浓度比(Seq/Coad)为1.01(95%可信区间[CI], 0.89-1.13), mrna -1273增强剂后1个月的抗spike抗体校正几何平均浓度比(Seq/Coad)为1.09 (95% CI 0.90-1.32)。在两个研究组之间,不良事件的总体频率、强度或持续时间没有观察到临床相关的差异。大多数征求的不良事件为轻度/中度强度,每个不良事件的中位持续时间[≤]2.5天。两组患者均以给药部位疼痛和肌痛最为常见。结论:在年龄≥50岁的成人中,mRNA-1273加强疫苗与RZV联合接种在免疫学上不逊于序贯给药,其安全性和反应原性与两种疫苗序贯给药一致(clinicaltrials.gov NCT05047770)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
No immunological interference or safety concerns when adjuvanted recombinant zoster vaccine is coadministered with a COVID-19 mRNA-1273 booster vaccine in adults aged 50 years and older: A randomized trial
Background: There is growing consensus that COVID-19 booster vaccines may be coadministered with other age-appropriate vaccines. Adding to the limited available data supporting coadministration, especially with adjuvanted vaccines, could enhance vaccine coverage in adults. Methods: In this phase 3, randomized, open-label study, eligible adults aged [≥]50 years were randomly assigned (1:1) to receive mRNA-1273 (50g) booster vaccination and a first dose of recombinant zoster vaccine (RZV1) 2 weeks apart (Seq group) or concomitantly (Coad group). The second RZV dose (RZV2) was administered 2 months post RZV1 in both groups. Primary objectives were noninferiority of anti-glycoprotein E and anti-Spike protein antibody responses in the Coad group compared to the Seq group. Safety and further immunogenicity assessments were secondary objectives. Results: 273 participants were randomized to the Seq group, 272 to the Coad group. Protocol-specified non-inferiority criteria were met. The adjusted geometric mean concentration ratio (Seq/Coad) was 1.01 (95% confidence interval [CI], 0.89-1.13) for anti-gE antibodies 1-month post-RZV2, and 1.09 (95% CI 0.90-1.32) for anti-Spike antibodies 1-month post-mRNA-1273 booster. No clinically relevant differences were observed in overall frequency, intensity, or duration of adverse events between the 2 study groups. Most solicited adverse events were mild/moderate in intensity, each with median duration [≤]2.5 days. Administration site pain and myalgia were the most frequently reported in both groups. Conclusions: Coadministration of mRNA-1273 booster vaccine with RZV in adults aged [≥]50 years was immunologically noninferior to sequential administration and had a safety and reactogenicity profile consistent with both vaccines administered sequentially (clinicaltrials.gov NCT05047770).
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信