Moderna has dosed the first subjects in a Phase III clinical trial of its seasonal influenza vaccine candidate, mRNA-1010.
The vaccine candidate encodes for hemagglutinin (HA) glycoproteins of the four influenza strains that the World Health Organization (WHO) recommended to prevent influenza, including influenza A/H1N1, A/H3N2, and influenza B/Yamagata- and B/Victoria-lineages.
HA is a key influenza surface glycoprotein thought to be a crucial target to elicit wide-ranging protection against influenza.
Furthermore, it is the key target of influenza vaccines that are available presently.
The randomised, observer-blind trial will assess the safety and immunological non-inferiority of the mRNA-1010 vaccine versus a licenced seasonal influenza vaccine in adults aged 18 years and above.
Subjects will be randomised into a 1:1 ratio to receive either one dose of mRNA-1010 vaccine or a licenced seasonal influenza vaccine as a comparator.
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The company expects to enrol nearly 6,000 adult subjects from Southern Hemisphere countries into the trial.
Moderna CEO Stéphane Bancel said: “We are pleased to begin this Phase III study of our seasonal influenza vaccine candidate, mRNA-1010, our fourth mRNA vaccine candidate to begin a pivotal Phase III study.
“mRNA-1010 is the first of several influenza vaccine candidates we are developing with the aim of iteratively improving traditional vaccines by inducing broad and robust immune responses.
“We believe our mRNA platform, with the flexibility and speed of our manufacturing process, is well-positioned to address the significant unmet need in seasonal flu.”
The company currently has four programmes in late-stage Phase III trials, including its SARS-CoV-2 booster, respiratory syncytial virus (RSV), seasonal flu and cytomegalovirus (CMV) vaccine candidates.
In May this year, Moderna and non-profit scientific research organisation IAVI announced plans to begin Phase I IAVI G003 trial of a human immunodeficiency virus (HIV) vaccine antigen, mRNA-1644, in Rwanda and South Africa.
Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.
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