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一种基于 mRNA 的四价季节性流感疫苗(mRNA-1010)在健康成年人中进行的 1/2 期随机临床试验的安全性和免疫原性:中期分析。

Safety and immunogenicity of a phase 1/2 randomized clinical trial of a quadrivalent, mRNA-based seasonal influenza vaccine (mRNA-1010) in healthy adults: interim analysis.

机构信息

Moderna, Inc., Cambridge, MA, USA.

Meridian Clinical Research, Sioux City, IA, USA.

出版信息

Nat Commun. 2023 Jun 19;14(1):3631. doi: 10.1038/s41467-023-39376-7.


DOI:10.1038/s41467-023-39376-7
PMID:37336877
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10279702/
Abstract

Despite vaccine availability, influenza remains a substantial global public health concern. Here, we report interim findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of a quadrivalent messenger RNA (mRNA) vaccine against seasonal influenza, mRNA-1010, from the first 2 parts of a 3-part, first-in-human, phase 1/2 clinical trial in healthy adults aged ≥18 years (NCT04956575). In the placebo-controlled Part 1, a single dose of mRNA-1010 (50 µg, 100 µg, or 200 µg) elicited hemagglutination inhibition (HAI) titers against vaccine-matched strains. In the active-comparator-controlled Part 2, mRNA-1010 (25 µg, 50 µg, or 100 µg) elicited higher HAI titers than a standard dose, inactivated seasonal influenza vaccine for influenza A strains and comparable HAI titers for influenza B strains. No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active comparator. These interim data support continued development of mRNA-1010.

摘要

尽管有疫苗可用,但流感仍然是一个重大的全球公共卫生关注点。在这里,我们报告了一项三部分、首次人体、1/2 期临床试验的前两部分的安全性、反应原性和体液免疫原性的主要和次要目标的临时结果,该试验评估了针对季节性流感的四价信使 RNA(mRNA)疫苗 mRNA-1010,纳入了年龄≥18 岁的健康成年人(NCT04956575)。在安慰剂对照的第 1 部分中,单剂量的 mRNA-1010(50µg、100µg 或 200µg)可诱导针对疫苗匹配株的血凝抑制(HAI)滴度。在活性对照第 2 部分中,mRNA-1010(25µg、50µg 或 100µg)比标准剂量的、用于甲型流感株的灭活季节性流感疫苗产生更高的 HAI 滴度,且对乙型流感株产生可比的 HAI 滴度。未发现安全性问题;与活性对照相比,疫苗接种后,mRNA-1010 引起的不良事件更频繁,且与剂量相关。这些中期数据支持继续开发 mRNA-1010。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/42e1bcde4af2/41467_2023_39376_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/3cc816b28f19/41467_2023_39376_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/59180cd9daf2/41467_2023_39376_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/4a48808f16d4/41467_2023_39376_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/68583dfeaa40/41467_2023_39376_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/42e1bcde4af2/41467_2023_39376_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/3cc816b28f19/41467_2023_39376_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/59180cd9daf2/41467_2023_39376_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/4a48808f16d4/41467_2023_39376_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/68583dfeaa40/41467_2023_39376_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6d46/10279702/42e1bcde4af2/41467_2023_39376_Fig5_HTML.jpg

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[3]
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[8]
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本文引用的文献

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