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News|Articles|October 26, 2023

Moderna Begins Phase 3 Trial for its Influenza-COVID-19 Vaccine

The company dosed its first study participant with its investigational vaccine, mRNA-1083. And this follows recent data reported from their phase 1/2 trial where the vaccine showed strong immunogenicity against influenza and COVID-19, with an acceptable reactogenicity and safety profile.

Moderna announced in a statement this week that their phase 3 study has begun and their first participant in the United States has been dosed with the company’s Influenza-COVID-19 vaccine combination vaccine candidate, mRNA-1083. The trial is expected to enroll approximately 8000 adults in the northern hemisphere.

Moderna said the phase 3 study will evaluate the immunogenicity, safety, and reactogenicity of mRNA‐1083 as compared with active control, co‐administered licensed influenza and SAR‐CoV‐2 vaccines in 2 independent age‐group sub‐study cohorts involving 4,000 adults 65 years and older and 4,000 adults 50 to <65 years of age.

The mRNA-1083 candidate selected to advance to phase 3 achieved hemagglutination inhibition antibody titers similar to or greater than both licensed quadrivalent influenza vaccines and achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster in the phase 1/2 study.

The vaccine candidate 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, the company said. The company sees an unmet need for this combination vaccine as they believe it may help in getting more people to get immunizations for these respiratory viruses.

What You Need to Know

Moderna has commenced its phase 3 study for the mRNA-1083 combination vaccine, which targets both influenza and COVID-19. The trial aims to enroll approximately 8,000 adults in the northern hemisphere, and it will evaluate the vaccine's immunogenicity, safety, and reactogenicity compared to licensed influenza and SAR-CoV-2 vaccines in two separate age-group sub-study cohorts, involving 4,000 adults aged 65 and older and 4,000 adults aged 50 to <65 years.

Earlier this month, Moderna released data from its phase 1/2 trial, which showed that the mRNA-1083 candidate had achieved strong antibody responses. The vaccine demonstrated hemagglutination inhibition antibody titers similar to or greater than licensed influenza vaccines and SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster.

The safety profile of mRNA-1083 was reported to be similar to that of the standalone COVID-19 vaccine group, with most adverse reactions being of mild to moderate severity.

Phase 1/2 Results

Earlier this month, the company announced data from its phase 1/2 trial, which was a randomized, observer blind study that evaluated the safety and immunogenicity of mRNA-1083 compared to a standard dose of the influenza vaccine, Fluarix, in adults 50-64 years of age and against an enhanced influenza vaccine, Fluzone HD, in adults 65-79 years of age.

For both age groups, mRNA-1083 was compared against Spikevax booster. The mRNA-1083 candidate selected to advance to phase 3 achieved hemagglutination inhibition antibody titers similar to or greater than both licensed quadrivalent influenza vaccines and achieved SARS-CoV-2 neutralizing antibody titers similar to the Spikevax bivalent booster in the phase 1/2 study.

The mRNA-1083 vaccine resulted in geometric mean titer (GMT) ratios >1.0 relative to Fluarix in adults 50-64 years of age, for all four influenza vaccine strains. GMT ratios for mRNA-1083 relative to Fluzone HD in adults 65-79 were also >1.0, for all four influenza vaccine strains. The GMT ratios of mRNA-1083 relative to Spikevax bivalent were > 0.9 in adults 50 to 64 years of age and > 1.0 in adults 65 to 79 years of age, relative to Spikevax.

The Safety Profile
Reported rates of solicited local and systemic adverse reactions for mRNA-1083 administration were similar to the standalone COVID-19 vaccine group in the trial. The majority of solicited adverse reactions were grade 1 or 2 in severity. Grade 3 solicited local or solicited systemic reactions were reported in less than 4% of participants ages 50 and above. No new safety concerns were identified for mRNA-1083 compared to the standalone vaccines.

The company is targeting a potential regulatory approval for the combination vaccine in 2025.

Reference

Moderna Announces First Participant Dosed in Phase 3 Study of mRNA-1083, a Combination Vaccine Against Influenza and COVID-19. Moderna press release. October 24, 2023. Accessed October 26, 2023.

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