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Combination Influenza/COVID-19 Vaccine Enters Phase 3 Trial, First Participant Dosed
The investigational combination vaccine against influenza and SARS-CoV-2 proved both safe and effective in recent results from a phase 1/2 trial, said Moderna.
The first participant has been dosed in the phase 3 clinical trial of mRNA-1083, an investigational combination vaccine candidate that protects against influenza and COVID-19 being studied by Moderna. Investigators anticipate enrolling approximately 8000 individuals in the Northern Hemisphere for the trial, according to a Moderna press release.1
The vaccine will be analyzed for immunogenicity, safety, and reactogenicity compared to active control, co‐administered licensed influenza and SAR‐CoV‐2 vaccines in independent age‐group substudy cohorts of approximately 4000 individuals aged 65 years and older and 4000 individuals aged 50 to 64 years.1
Results released earlier this month from a phase 1/2 trial showed mRNA-1083 achieved hemagglutination inhibition antibody titers similar to or greater than the 2 licensed quadrivalent influenza vaccines as well as SARS-CoV-2 neutralizing antibody titers similar to the company’s Spikevax bivalent booster.2
The randomized, observer-blind phase 1/2 clinical trial evaluated the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine, Fluarix (GSK), in adults 50-64 years of age and against an enhanced influenza vaccine, Fluzone HD (Sanofi), in adults 65-79 years of age.2
For both age groups, mRNA-1083 was compared to a standard dose of Moderna’s Spikevax COVID-19 bivalent booster shot.2
Results
Investigators found that mRNA-1083 resulted in geometric mean titer (GMT) ratios of 1.0 or greater relative to Fluarix for all 4 influenza vaccine strains in adults aged 50 to 64 years. GMT ratios for the vaccine were also 1.0 or greater relative to Fluzone HD in participants aged 65 to 79 years, also in all 4 vaccine strains.2
Read more: Moderna Investigational Dual Flu/COVID-19 Vaccine Shows Positive Phase 1/2 Results
In the comparison of mRNA-1083 with Spikevax, GMT ratios were 0.9 or greater for those aged 50 to 64 years and 1.0 or greater for those aged 65 to 79 years.2
The rates of solicited local and systemic adverse reactions after mRNA-1083 administration were similar to the COVID-19 vaccine group, according to Moderna.2 The majority of solicited reactions were grade 1 or 2 in severity, with grade 3 reactions reported in less than 3% of individuals aged 50 years and older.2 There were no new safety concerns identified for the investigational vaccine compared to the standalone vaccines.2
“mRNA‐1083 has the potential to efficiently reduce the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza and SARS‐CoV‐2 viruses in a single injection,” Moderna said in today's announcement.1 “mRNA‐1083 offers greater convenience and has the potential to lead to increased compliance with vaccine recommendations. This approach could benefit public health by synergistically increasing coverage rates against influenza and SARS‐CoV‐2 viruses.”
Moderna said it anticipates seeking initial regulatory approval for mRNA‐1083 in 2025.1
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