tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2025 Dec;21(1):2484088.
doi: 10.1080/21645515.2025.2484088. Epub 2025 Apr 2. An mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers
Boris Kandinov[SUP] 1 [/SUP], Mieke Soens[SUP] 1 [/SUP], Wenmei Huang[SUP] 1 [/SUP], Conrado Llapur[SUP] 2 [/SUP], David Ensz[SUP] 3 [/SUP], Brandon Essink[SUP] 4 [/SUP], Carlos Fierro[SUP] 5 [/SUP], Jignesh Vakil[SUP] 1 [/SUP], Alicia Pucci[SUP] 1 [/SUP], Jia Guo[SUP] 1 [/SUP], Sinead Rudden[SUP] 1 [/SUP], Kristi Hall[SUP] 1 [/SUP], Bryony Hicks[SUP] 6 [/SUP], Kristin Schaefers[SUP] 1 [/SUP], Honghong Zhou[SUP] 1 [/SUP], Chong Ma[SUP] 1 [/SUP], Lingyi Zheng[SUP] 1 [/SUP], Andrei Avanesov[SUP] 1 [/SUP], Yoonyoung Park[SUP] 1 [/SUP], Evelyn Du[SUP] 1 [/SUP], Jacqueline Miller[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 1 [/SUP], Raffael Nachbagauer[SUP] 1 [/SUP]
Affiliations
The safety, immunogenicity, and efficacy of the original formulation of the investigational mRNA-1010 vaccine for seasonal influenza were investigated in two randomized, active-controlled, phase 3 trials in adults (NCT05415462 and NCT05566639), and the results were used to evaluate hemagglutination inhibition (HAI) titers as correlates of risk and protection against influenza-like illness. mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials. The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains and lower responses against influenza B strains relative to an active comparator (licensed inactivated influenza vaccine). An analysis of HAI titers as a correlate of protection against influenza infection provided support for its use as a surrogate endpoint for mRNA-1010, similar to licensed influenza vaccines. These findings support further optimization and development of mRNA-1010 against seasonal influenza.
Keywords: Seasonal influenza; correlate of protection; immunogenicity; mRNA vaccine; reactogenicity; safety.
. 2025 Dec;21(1):2484088.
doi: 10.1080/21645515.2025.2484088. Epub 2025 Apr 2. An mRNA-based seasonal influenza vaccine in adults: Results of two phase 3 randomized clinical trials and correlate of protection analysis of hemagglutination inhibition titers
Boris Kandinov[SUP] 1 [/SUP], Mieke Soens[SUP] 1 [/SUP], Wenmei Huang[SUP] 1 [/SUP], Conrado Llapur[SUP] 2 [/SUP], David Ensz[SUP] 3 [/SUP], Brandon Essink[SUP] 4 [/SUP], Carlos Fierro[SUP] 5 [/SUP], Jignesh Vakil[SUP] 1 [/SUP], Alicia Pucci[SUP] 1 [/SUP], Jia Guo[SUP] 1 [/SUP], Sinead Rudden[SUP] 1 [/SUP], Kristi Hall[SUP] 1 [/SUP], Bryony Hicks[SUP] 6 [/SUP], Kristin Schaefers[SUP] 1 [/SUP], Honghong Zhou[SUP] 1 [/SUP], Chong Ma[SUP] 1 [/SUP], Lingyi Zheng[SUP] 1 [/SUP], Andrei Avanesov[SUP] 1 [/SUP], Yoonyoung Park[SUP] 1 [/SUP], Evelyn Du[SUP] 1 [/SUP], Jacqueline Miller[SUP] 1 [/SUP], Jintanat Ananworanich[SUP] 1 [/SUP], Raffael Nachbagauer[SUP] 1 [/SUP]
Affiliations
- PMID: 40174609
- DOI: 10.1080/21645515.2025.2484088
The safety, immunogenicity, and efficacy of the original formulation of the investigational mRNA-1010 vaccine for seasonal influenza were investigated in two randomized, active-controlled, phase 3 trials in adults (NCT05415462 and NCT05566639), and the results were used to evaluate hemagglutination inhibition (HAI) titers as correlates of risk and protection against influenza-like illness. mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials. The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains and lower responses against influenza B strains relative to an active comparator (licensed inactivated influenza vaccine). An analysis of HAI titers as a correlate of protection against influenza infection provided support for its use as a surrogate endpoint for mRNA-1010, similar to licensed influenza vaccines. These findings support further optimization and development of mRNA-1010 against seasonal influenza.
Keywords: Seasonal influenza; correlate of protection; immunogenicity; mRNA vaccine; reactogenicity; safety.