Moderna confirmed Thursday that it expects to begin dosing in its Phase III study of mRNA-1273, an mRNA vaccine candidate against COVID-19, in July. The company first mentioned the target data for the trial last month when it reported positive interim data from a Phase I study of the vaccine candidate.
According to Moderna, the protocol for the late-stage study has been finalised based on feedback from the FDA, with approximately 30,000 patients in the US expected to be randomised to receive mRNA-1273 or placebo. The trial, which will be conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), will assess the prevention of symptomatic COVID-19 disease as its primary endpoint, while key secondary goals include prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2.
Dose of 100 mcg chosen
Moderna said that the dose to be used in the Phase III study is 100 mcg, allowing it to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses annually, beginning in 2021, from the company’s US manufacturing site and ongoing collaboration with Lonza. The drugmaker added that it has completed manufacturing the vaccine required to start the trial.
Meanwhile, Moderna noted that a Phase II trial of mRNA-1273 has already fully enrolled the 300 participants in the younger adult cohort, while it has also completed enrollment of the 50 people making up the sentinel group of older adults. Overall, the company plans to recruit a total of 600 healthy participants across the two cohorts, which aside from the 300 people in the 18-to-54 age group, will also include 300 subjects in the over-55 category. The placebo-controlled mid-stage study is testing 50-mcg and 100-mcg doses of mRNA-1273, each given twice, 28 days apart, with participants followed through 12 months after the second vaccination.
The announcement from Moderna comes the day after John Mascola, director of NIAID’s vaccine research centre, suggested that mRNA-1273 would be the first of three COVID-19 vaccines to enter decisive studies backed by the US government this summer. The other vaccines include AstraZeneca and the University of Oxford’s AZD1222 and Johnson & Johnson’s Ad26.COV2-S, with late-stage trials of these targeted for August and September, respectively.
June 11th, 2020