ArticleInfectious diseases and therapy2026
A Phase 2 Trial Evaluating the Immunogenicity and Safety of an mRNA-Based Seasonal Influenza Vaccine Candidate Encoding Hemagglutinin and Neuraminidase.
Article in Infectious diseases and therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06431607 (A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate the Immunogenicity and Safety of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older), which is not on this map. Not yet cited in PubMed.
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A Phase 2a Randomized, Observer-blind, Dose-finding Study to Evaluate the Immunogenicity and Safety of mRNA-based Multivalent Seasonal Influenza Vaccine Candidates in Adults 18 Years of Age and Older
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Abstract
introductionInfluenza vaccines targeting both hemagglutinin (HA) and neuraminidase (NA) might offer broader protection than current vaccines, which primarily target HA. This randomized phase 2 study evaluated the immunogenicity and safety of an investigational mRNA-based trivalent seasonal influenza vaccine encoding HA and NA from A/H1N1, A/H3N2, and B/Victoria (FLUm3HA-3NA).
methodsParticipants aged 18-64 years (younger adults) or 65-85 years (older adults) received one of several mRNA vaccine formulations-each containing different influenza A and B HA mRNA doses-or an age-appropriate licensed seasonal influenza vaccine as a comparator. Four formulations per age cohort were tested in part 1 of the study, and one formulation per age cohort in part 2. Day-29 hemagglutination inhibition (HI) and NA inhibition (NI) responses were assessed as primary and secondary endpoints, respectively, safety/reactogenicity as the secondary, and virus neutralization as the tertiary endpoint.
resultsA total of 250 younger and 260 older adults were vaccinated in part 1; 161 and 162, respectively, in part 2. All FLUm3HA-3NA formulations induced HI, NI, and neutralizing responses above baseline. In part 1, HI responses against A/H1N1 and A/H3N2 were similar or higher after FLUm3HA-3NA than after comparator vaccination in both age groups. For B/Victoria, HI responses were lower or similar versus comparator vaccination in younger adults and similar or higher in older adults. In part 2, HI responses were similar or higher with FLUm3HA-3NA versus comparators for A/H1N1 and A/H3N2, and lower for B/Victoria in both age groups. In both study parts and both age groups, NI titers were higher for all three strains with FLUm3HA-3NA versus comparators, and neutralizing titers were similar or higher for A/H1N1 and A/H3N2 and similar for B/Victoria. No safety concerns were identified.
conclusionsFLUm3HA-3NA induced HI, NI, and neutralizing responses, with an acceptable safety profile. The results support further development, including optimization of the influenza B HI response.
trial registrationClinicalTrials.gov: NCT06431607.
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