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

Ivan T. Lee, Raffael Nachbagauer (), David Ensz, Howard Schwartz, Lizbeth Carmona, Kristi Schaefers, Andrei Avanesov, Daniel Stadlbauer, Carole Henry, Ren Chen, Wenmei Huang, Daniela Ramirez Schrempp, Jintanat Ananworanich and Robert Paris ()
Additional contact information
Ivan T. Lee: Moderna, Inc.
Raffael Nachbagauer: Moderna, Inc.
David Ensz: Meridian Clinical Research
Howard Schwartz: Research Centers of America
Lizbeth Carmona: Moderna, Inc.
Kristi Schaefers: Moderna, Inc.
Andrei Avanesov: Moderna, Inc.
Daniel Stadlbauer: Moderna, Inc.
Carole Henry: Moderna, Inc.
Ren Chen: Moderna, Inc.
Wenmei Huang: Moderna, Inc.
Daniela Ramirez Schrempp: Moderna, Inc.
Jintanat Ananworanich: Moderna, Inc.
Robert Paris: Moderna, Inc.

Nature Communications, 2023, vol. 14, issue 1, 1-11

Abstract: 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.

Date: 2023
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DOI: 10.1038/s41467-023-39376-7

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