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 : 2025-02-07 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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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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