Humoral Immunogenicity of mRNA-1010, an mRNA-based Seasonal Influenza Vaccine, in Adults ≥50 Years.
- 1Department of Diagnostic Sciences, Center for Vaccinology, Ghent University and Ghent University Hospital, Ghent, Belgium.
- 2Moderna, Inc., Cambridge, Massachusetts, USA.
Abstract
Background
Seasonal influenza causes substantial morbidity and mortality worldwide. In a phase 3 study in adults ≥50 years, trivalent mRNA-1010 demonstrated superior efficacy vs a standard-dose (SD) seasonal influenza vaccine. This analysis reports humoral immunogenicity.Methods
Participants were randomized 1:1 to a single dose of mRNA-1010 (37.5-µg) or licensed SD influenza vaccine. Immunogenicity was assessed in a prespecified per-protocol subset. Antihemagglutinin antibody titers were measured by hemagglutination inhibition (HAI) and microneutralization (MN; subset) at baseline and day 29 against vaccine-matched strains. Outcomes included geometric mean titers (GMTs), geometric mean fold rises (GMFRs) from baseline, and seroconversion rates (SCRs; ≥4-fold rise).Results
The Per-Protocol Immunogenicity Subset included 2342 participants (mRNA-1010, n = 1167; SD influenza vaccine, n = 1175). mRNA-1010 induced higher levels of HAI antibodies relative to SD influenza vaccine. mRNA-1010 increased HAI GMTs, with day 29 GMFRs of 4.07 (A/H1N1), 4.70 (A/H3N2), and 3.14 (B/Victoria). Geometric mean ratio point estimates vs SD influenza vaccine exceeded 1.5 across all strains, with lower bounds (LBs) of 95% CIs all exceeding 1.4: 1.82 (95% confidence interval [CI], 1.69-1.97), 1.59 (1.48-1.71), and 1.67 (1.57-1.78), respectively. Similarly, SCR differences were positive; LBs >15: 27.95% (95% CI: 24.09-31.73), 19.99% (15.99-23.92), and 25.33% (21.65-28.95), respectively. mRNA-1010 elicited higher MN antibody responses vs SD influenza vaccine for all 3 strains.Conclusions
In adults ≥50 years, a single dose of mRNA-1010 induced higher humoral immune responses against vaccine-matched influenza strains than licensed SD influenza vaccine. Together with previously reported results, these findings support mRNA-1010 as a seasonal influenza vaccine option in adults ≥50 years.Clinical trials registration
NCT06602024.
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BibTeX
@article{lerouxroels2026humoral,
title = {{Humoral Immunogenicity of mRNA-1010, an mRNA-based Seasonal Influenza Vaccine, in Adults ≥50 Years.}},
author = {Isabel Leroux-Roels and Elissa Malkin and HuiLing Chen and Andrei Avanesov and Ren Chen and Brianna Fidler and Rituparna Das and Eleanor Wilson},
journal = {Open forum infectious diseases},
year = {2026},
month = oct,
doi = {10.1093/ofid/ofag646},
url = {https://europepmc.org/article/MED/42921512},
note = {CC BY},
}
RIS
TY - JOUR
TI - Humoral Immunogenicity of mRNA-1010, an mRNA-based Seasonal Influenza Vaccine, in Adults ≥50 Years.
AU - Isabel Leroux-Roels
AU - Elissa Malkin
AU - HuiLing Chen
AU - Andrei Avanesov
AU - Ren Chen
AU - Brianna Fidler
AU - Rituparna Das
AU - Eleanor Wilson
PY - 2026
DA - 2026/10/13
JO - Open forum infectious diseases
DO - 10.1093/ofid/ofag646
UR - https://europepmc.org/article/MED/42921512
AB - Background Seasonal influenza causes substantial morbidity and mortality worldwide. In a phase 3 study in adults ≥50 years, trivalent mRNA-1010 demonstrated superior efficacy vs a standard-dose (SD) seasonal influenza vaccine. This analysis reports humoral immunogenicity.Methods Participants were randomized 1:1 to a single dose of mRNA-1010 (37.5-µg) or licensed SD influenza vaccine. Immunogenicity was assessed in a prespecified per-protocol subset. Antihemagglutinin antibody titers were measured by hemagglutination inhibition (HAI) and microneutralization (MN; subset) at baseline and day 29 against vaccine-matched strains. Outcomes included geometric mean titers (GMTs), geometric mean fold rises (GMFRs) from baseline, and seroconversion rates (SCRs; ≥4-fold rise).Results The Per-Protocol Immunogenicity Subset included 2342 participants (mRNA-1010, n = 1167; SD influenza vaccine, n = 1175). mRNA-1010 induced higher levels of HAI antibodies relative to SD influenza vaccine. mRNA-1010 increased HAI GMTs, with day 29 GMFRs of 4.07 (A/H1N1), 4.70 (A/H3N2), and 3.14 (B/Victoria). Geometric mean ratio point estimates vs SD influenza vaccine exceeded 1.5 across all strains, with lower bounds (LBs) of 95% CIs all exceeding 1.4: 1.82 (95% confidence interval [CI], 1.69-1.97), 1.59 (1.48-1.71), and 1.67 (1.57-1.78), respectively. Similarly, SCR differences were positive; LBs >15: 27.95% (95% CI: 24.09-31.73), 19.99% (15.99-23.92), and 25.33% (21.65-28.95), respectively. mRNA-1010 elicited higher MN antibody responses vs SD influenza vaccine for all 3 strains.Conclusions In adults ≥50 years, a single dose of mRNA-1010 induced higher humoral immune responses against vaccine-matched influenza strains than licensed SD influenza vaccine. Together with previously reported results, these findings support mRNA-1010 as a seasonal influenza vaccine option in adults ≥50 years.Clinical trials registration NCT06602024.
SN - 2328-8957
ER -