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mRNA-1345 RSV 疫苗在老年人中的体液免疫原性。

Humoral Immunogenicity of mRNA-1345 RSV Vaccine in Older Adults.

机构信息

Infectious Disease, Research and Development, Moderna, Inc., Cambridge, Massachusetts.

Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

出版信息

J Infect Dis. 2024 Nov 15;230(5):e996-e1006. doi: 10.1093/infdis/jiae316.

DOI:10.1093/infdis/jiae316
PMID:38889247
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11566230/
Abstract

BACKGROUND

The mRNA-1345 vaccine demonstrated efficacy against respiratory syncytial virus (RSV) disease with acceptable safety in adults aged ≥60 years in the ConquerRSV trial. Here, humoral immunogenicity results from the trial are presented.

METHODS

This phase 2/3 trial randomly assigned adults (≥60 years) to mRNA-1345 50-µg encoding prefusion F (preF) glycoprotein (n = 17 793) vaccine or placebo (n = 17 748). RSV-A and RSV-B neutralizing antibody (nAb) and preF binding antibody (bAb) levels at baseline and day 29 postvaccination were assessed in a per-protocol immunogenicity subset (PPIS; mRNA-1345, n = 1515; placebo, n = 333).

RESULTS

Day 29 nAb geometric mean titers (GMTs) increased 8.4-fold against RSV-A and 5.1-fold against RSV-B from baseline. Seroresponses (4-fold rise from baseline) in the mRNA-1345 groups were 74.2% and 56.5% for RSV-A and RSV-B, respectively. Baseline GMTs were lower among participants who met the seroresponse criteria than those who did not. mRNA-1345 induced preF bAbs at day 29, with a pattern similar to nAbs. Day 29 antibody responses across demographic and risk subgroups were generally consistent with the overall PPIS.

CONCLUSIONS

mRNA-1345 enhanced RSV-A and RSV-B nAbs and preF bAbs in adults (≥60 years) across various subgroups, including those at risk for severe disease, consistent with its demonstrated efficacy in the prevention of RSV disease.

CLINICAL TRIALS REGISTRATION

NCT05127434.

摘要

背景

在 ConquerRSV 试验中，mRNA-1345 疫苗在 60 岁及以上成年人中显示出针对呼吸道合胞病毒 (RSV) 疾病的疗效，且安全性可接受。此处呈现的是该试验的体液免疫原性结果。

方法

这项 2/3 期试验将成年人（≥60 岁）随机分配至 50-μg 编码融合前 F（preF）糖蛋白的 mRNA-1345 疫苗（n=17793）或安慰剂（n=17748）。在符合方案免疫亚组（PPIS；mRNA-1345，n=1515；安慰剂，n=333）中，评估了 RSV-A 和 RSV-B 中和抗体（nAb）和 preF 结合抗体（bAb）在基线和接种后第 29 天的水平。

结果

与基线相比，接种第 29 天 RSV-A 和 RSV-B 的 nAb 几何平均滴度（GMT）分别增加了 8.4 倍和 5.1 倍。mRNA-1345 组针对 RSV-A 和 RSV-B 的血清学应答率（较基线升高 4 倍）分别为 74.2%和 56.5%。符合血清学应答标准的参与者的基线 GMT 低于不符合者。mRNA-1345 在第 29 天诱导了 preF bAb，其模式与 nAb 相似。在人口统计学和风险亚组中，第 29 天的抗体应答通常与总体 PPIS 一致。

结论

mRNA-1345 在 60 岁及以上成年人（≥60 岁）中增强了 RSV-A 和 RSV-B nAb 和 preF bAb，包括那些患有严重疾病风险的人，这与该疫苗在预防 RSV 疾病方面的疗效一致。

临床试验注册

NCT05127434。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/fda8f0d4e940/jiae316f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/f212e9cf7d85/jiae316f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/6a1d54b80c1f/jiae316f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/26fd7dbb8e8f/jiae316f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/5f4fbde4b53a/jiae316f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/fda8f0d4e940/jiae316f5.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/f212e9cf7d85/jiae316f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/6a1d54b80c1f/jiae316f2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/26fd7dbb8e8f/jiae316f3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/5f4fbde4b53a/jiae316f4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a294/11566230/fda8f0d4e940/jiae316f5.jpg

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