tetano
Editor, Senior Moderator
Nat Med
. 2025 Mar 18.
doi: 10.1038/s41591-025-03591-0. Online ahead of print. mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial
Amanda K Rudman Spergel[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 1 [/SUP], Ruiting Guo[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], Lizbeth Carmona[SUP] 2 [/SUP], Kristin Schaefers[SUP] 1 [/SUP], Yamuna D Paila[SUP] 1 [/SUP], Boris Kandinov[SUP] 1 [/SUP], Charles H Eger[SUP] 3 [/SUP], Melissa Sinkiewicz[SUP] 1 [/SUP], Sarah Shao[SUP] 1 [/SUP], Carole Henry[SUP] 1 [/SUP], Christine A Shaw[SUP] 4 [/SUP]
Affiliations
A multicomponent vaccine targeting several seasonal respiratory pathogens may provide simultaneous protection in a single-injection regimen. We present interim (28 days) findings from a phase 1/2 study of an mRNA-based multicomponent vaccine (mRNA-1083), encoding seasonal influenza and SARS-CoV-2 antigens. Adults (18-79 years) were randomly assigned to receive different compositions of mRNA-1083 at varying dose levels on day 1. The primary study objectives were reactogenicity through 7 days and safety through 28 days postvaccination, and the secondary study objective was immunogenicity against vaccine-matched influenza and SARS-CoV-2 strains at day 29 assessed by hemagglutination inhibition and pseudovirus neutralization assays, respectively. The multicomponent mRNA-1083 vaccine was generally well-tolerated, with most solicited adverse reactions being Grade 1 or 2 in severity. The incidence of unsolicited adverse events was similar across vaccine groups. mRNA-1083 induced immune responses against influenza and SARS-CoV-2 that were, in general, similar to or higher than those achieved with licensed quadrivalent influenza (standard or high dose) and SARS-CoV-2 (bivalent mRNA-1273) vaccines. These data support ongoing phase 3 evaluation of the mRNA-1083 vaccine. ClinicalTrials.gov registration: NCT05827926 .
. 2025 Mar 18.
doi: 10.1038/s41591-025-03591-0. Online ahead of print. mRNA-based seasonal influenza and SARS-CoV-2 multicomponent vaccine in healthy adults: a phase 1/2 trial
Amanda K Rudman Spergel[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 1 [/SUP], Ruiting Guo[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], Lizbeth Carmona[SUP] 2 [/SUP], Kristin Schaefers[SUP] 1 [/SUP], Yamuna D Paila[SUP] 1 [/SUP], Boris Kandinov[SUP] 1 [/SUP], Charles H Eger[SUP] 3 [/SUP], Melissa Sinkiewicz[SUP] 1 [/SUP], Sarah Shao[SUP] 1 [/SUP], Carole Henry[SUP] 1 [/SUP], Christine A Shaw[SUP] 4 [/SUP]
Affiliations
- PMID: 40102593
- DOI: 10.1038/s41591-025-03591-0
A multicomponent vaccine targeting several seasonal respiratory pathogens may provide simultaneous protection in a single-injection regimen. We present interim (28 days) findings from a phase 1/2 study of an mRNA-based multicomponent vaccine (mRNA-1083), encoding seasonal influenza and SARS-CoV-2 antigens. Adults (18-79 years) were randomly assigned to receive different compositions of mRNA-1083 at varying dose levels on day 1. The primary study objectives were reactogenicity through 7 days and safety through 28 days postvaccination, and the secondary study objective was immunogenicity against vaccine-matched influenza and SARS-CoV-2 strains at day 29 assessed by hemagglutination inhibition and pseudovirus neutralization assays, respectively. The multicomponent mRNA-1083 vaccine was generally well-tolerated, with most solicited adverse reactions being Grade 1 or 2 in severity. The incidence of unsolicited adverse events was similar across vaccine groups. mRNA-1083 induced immune responses against influenza and SARS-CoV-2 that were, in general, similar to or higher than those achieved with licensed quadrivalent influenza (standard or high dose) and SARS-CoV-2 (bivalent mRNA-1273) vaccines. These data support ongoing phase 3 evaluation of the mRNA-1083 vaccine. ClinicalTrials.gov registration: NCT05827926 .