Positive interim results from Moderna’s Phase I/II trial of mRNA-1083, an investigational vaccine designed to immunise against both influenza and COVID-19, have been released.
There are several benefits of the combination vaccine as a preventative measure against these respiratory conditions, according to the pharmaceutical company. For example: higher patient compliance, easier administration and greater convenience.
Data from Moderna’s mRNA-1083 Phase I/II trial
The ongoing Phase I/II clinical trial is evaluating the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine Fluarix, in adults aged 50-64. Additionally, the combination vaccine is being investigated against Fluzone HD, an enhanced influenza vaccine, in adults 65-79 years of age. According to Moderna, mRNA-1083 was compared against Spikevax booster in both age groups.
mRNA-1083 achieved hemagglutination inhibition antibody titers similar to or greater than both licensed quadrivalent influenza vaccines. Moreover, the combination vaccine achieved SARS-CoV-2 neutralising antibody titers similar to the Spikevax bivalent booster in the Phase I/II study, Moderna stated. No new safety concerns were identified for mRNA-1083 compared to the standalone vaccines in the study.
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The company also noted that the mRNA vaccine achieved:
- Geometric mean titer (GMT) ratios >0 relative to Fluarix in adults 50-64 years of age, for all four influenza vaccine strains
- mRNA-1083 GMT ratios relative to Fluzone HD in adults aged 65-79 were also >0. This was the case for all four influenza vaccine strains
- GMT ratios of mRNA-1083 relative to Spikevax bivalent were >9 in adults between 50 and 64 years old and >1.0 in adults 65 to 79 years of age, relative to Spikevax.
“We are excited to move combination respiratory vaccines into Phase III development,” stated Stéphane Bancel, Chief Executive Officer of Moderna. The company reported that a Phase III trial of mRNA-1083 for adults 50 years old and over is set to begin in 2023. A potential regulatory approval for the combination vaccine is targeted for 2025.
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