tetano
Editor, Senior Moderator
Vaccine
. 2025 Feb 6:50:126847.
doi: 10.1016/j.vaccine.2025.126847. Online ahead of print. A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults
Mieke Soens[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 2 [/SUP], Bryony Hicks[SUP] 3 [/SUP], Kathryn Jean Lucas[SUP] 4 [/SUP], Jose Cardona[SUP] 5 [/SUP], Lawrence Sher[SUP] 6 [/SUP], Greg Livermore[SUP] 2 [/SUP], Kristi Schaefers[SUP] 2 [/SUP], Carole Henry[SUP] 2 [/SUP], Angela Choi[SUP] 2 [/SUP], Andrei Avanesov[SUP] 2 [/SUP], Ren Chen[SUP] 2 [/SUP], Evelyn Du[SUP] 2 [/SUP], Alicia Pucci[SUP] 2 [/SUP], Rituparna Das[SUP] 2 [/SUP], Jacqueline Miller[SUP] 2 [/SUP], Raffael Nachbagauer[SUP] 2 [/SUP]
Affiliations
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.
Keywords: Immunogenicity; Reactogenicity; Safety; Seasonal influenza; mRNA vaccine; mRNA-1010.
. 2025 Feb 6:50:126847.
doi: 10.1016/j.vaccine.2025.126847. Online ahead of print. A phase 3 randomized safety and immunogenicity trial of mRNA-1010 seasonal influenza vaccine in adults
Mieke Soens[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 2 [/SUP], Bryony Hicks[SUP] 3 [/SUP], Kathryn Jean Lucas[SUP] 4 [/SUP], Jose Cardona[SUP] 5 [/SUP], Lawrence Sher[SUP] 6 [/SUP], Greg Livermore[SUP] 2 [/SUP], Kristi Schaefers[SUP] 2 [/SUP], Carole Henry[SUP] 2 [/SUP], Angela Choi[SUP] 2 [/SUP], Andrei Avanesov[SUP] 2 [/SUP], Ren Chen[SUP] 2 [/SUP], Evelyn Du[SUP] 2 [/SUP], Alicia Pucci[SUP] 2 [/SUP], Rituparna Das[SUP] 2 [/SUP], Jacqueline Miller[SUP] 2 [/SUP], Raffael Nachbagauer[SUP] 2 [/SUP]
Affiliations
- PMID: 39919447
- DOI: 10.1016/j.vaccine.2025.126847
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.
Keywords: Immunogenicity; Reactogenicity; Safety; Seasonal influenza; mRNA vaccine; mRNA-1010.