A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults

IF 4.5 3区医学 Q2 IMMUNOLOGY Vaccine Pub Date : 2025-03-19 Epub Date: 2025-02-07 DOI:10.1016/j.vaccine.2025.126847

Mieke Soens , Jintanat Ananworanich , Bryony Hicks , Kathryn Jean Lucas , Jose Cardona , Lawrence Sher , Greg Livermore , Kristi Schaefers , Carole Henry , Angela Choi , Andrei Avanesov , Ren Chen , Evelyn Du , Alicia Pucci , Rituparna Das , Jacqueline Miller , Raffael Nachbagauer

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Abstract

Background

Messenger RNA (mRNA)-based influenza vaccines have the potential to improve upon limitations of current vaccine approaches to seasonal influenza.

Methods

Here we report findings on the primary and secondary objectives of the safety, reactogenicity, and humoral immunogenicity of the quadrivalent mRNA vaccine, mRNA-1010, versus licensed standard-dose and high-dose quadrivalent influenza vaccines from a three-part, phase 3 clinical trial in adults aged ≥18 years (Part A), 18–64 years (Part B), and ≥ 65 years (Part C) (NCT05827978).

Results

A single 50-μg dose of mRNA-1010 elicited hemagglutination inhibition titers against vaccine-matched strains that were statistically noninferior and superior to licensed standard-dose and high-dose egg-based quadrivalent vaccine comparators. Solicited adverse reactions were more frequent with receipt of mRNA-1010; adverse reactions were lower in frequency and severity among adults aged ≥65 years than younger adults. No safety concerns were identified.

Conclusions

These findings support the potential benefit of mRNA-1010 as a seasonal influenza vaccine.

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成人mRNA-1010季节性流感疫苗的3期随机安全性和免疫原性试验

基于信使RNA （mRNA）的流感疫苗有潜力改进目前季节性流感疫苗方法的局限性。本文报告了四价mRNA疫苗mRNA-1010与已获许可的标准剂量和高剂量四价流感疫苗（NCT05827978）的安全性、反应原性和体液免疫原性的主要和次要目标，这些研究结果来自一项年龄≥18岁（a部分）、18 - 64岁（B部分）和≥65岁（C部分）成人的三部分iii期临床试验（NCT05827978）。结果单个50 μg剂量的mRNA-1010对疫苗匹配株的血凝抑制效价在统计学上不低于并优于许可的标准剂量和高剂量蛋基四价疫苗比较物。收到mRNA-1010后，征求不良反应更频繁；年龄≥65岁的成年人不良反应的发生频率和严重程度低于年轻人。没有发现安全隐患。结论：这些发现支持mRNA-1010作为季节性流感疫苗的潜在益处。

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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