Moderna doses first subject in Phase I/II trial of seasonal flu vaccine
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Moderna doses first subject in Phase I/II trial of seasonal flu vaccine

08 Jul 2021 (Last Updated July 8th, 2021 10:06)

The Phase I/II trial will assess the safety, reactogenicity and immunogenicity of mRNA-1010 in 180 adult subjects.

Moderna has dosed the first subjects in the Phase I/II clinical trial of its quadrivalent seasonal influenza mRNA vaccine candidate, mRNA-1010, in the US.

mRNA-1010 is the company’s first seasonal influenza vaccine candidate to enter the clinical development stage, Moderna noted.

It targets lineages listed by the World Health Organization (WHO) for influenza prevention, which includes seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria.

The randomised, stratified, observer-blind, dose-ranging Phase I/II trial will assess the safety, reactogenicity and immunogenicity of mRNA-1010 in healthy adult subjects aged 18 years or above.

A total of nearly 180 subjects will be enrolled in the trial.

Moderna CEO Stéphane Bancel said: “We believe that the advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses such as influenza, SARS-CoV-2 and RSV.

“Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses.”

Epidemics involving seasonal flu, including type A and type B, occur seasonally and can differ in severity every year, leading to respiratory ailments and putting a significant burden on healthcare systems.

According to the WHO, yearly, around three to five million severe flu cases and 290,000 to 650,000 cases of flu-linked respiratory deaths are reported worldwide.

The presently available flu vaccines are nearly 40-60% efficient and their formulation is fixed six to nine months before the anticipated use.

In addition, egg-based vaccine production can trigger unintended antigenic modification to the vaccine virus. This production method is utilised by the majority of presently licensed influenza vaccines.

Moderna intends to study a potential combination of vaccines for flu, SARS-CoV-2, respiratory syncytial virus (RSV), and human metapneumovirus.

The company’s seasonal influenza programme will also analyse various candidates exploring separate antigen combinations against seasonal influenza in the clinic.

Earlier this year, the US National Institutes of Health initiated dosing in a new Phase I trial of Moderna’s investigational Covid-19 vaccine candidate, mRNA-1273.351, in adult subjects.