Kandinov Boris, Soens Mieke, Huang Wenmei, Llapur Conrado, Ensz David, Essink Brandon, Fierro Carlos, Vakil Jignesh, Pucci Alicia, Guo Jia, Rudden Sinead, Hall Kristi, Hicks Bryony, Schaefers Kristin, Zhou Honghong, Ma Chong, Zheng Lingyi, Avanesov Andrei, Park Yoonyoung, Du Evelyn, Miller Jacqueline, Ananworanich Jintanat, Nachbagauer Raffael
Development, Moderna Inc, Cambridge, MA, USA.
Clínica Mayo de UMCB SRL, Tucuman, Argentina.
Hum Vaccin Immunother. 2025 Dec;21(1):2484088. doi: 10.1080/21645515.2025.2484088. Epub 2025 Apr 2.
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.
在两项针对成人的随机、活性对照3期试验（NCT05415462和NCT05566639）中，对研究性mRNA-1010季节性流感疫苗原始配方的安全性、免疫原性和有效性进行了调查，研究结果用于评估血凝抑制（HAI）滴度，作为流感样疾病风险和防护的相关指标。在两项试验中接种疫苗的14,000多名成年参与者中，mRNA-1010（50µg）表现出可接受的反应原性和安全性。相对于活性对照（已获许可的灭活流感疫苗），mRNA-1010的有效性总体上反映了免疫原性结果，对甲型流感毒株的免疫反应较高，对乙型流感毒株的反应较低。将HAI滴度作为预防流感感染的相关指标进行分析，为其作为mRNA-1010替代终点的用途提供了支持，这与已获许可的流感疫苗类似。这些发现支持对mRNA-1010针对季节性流感进行进一步优化和开发。
