Moderna has finalised a protocol for the Phase 3 randomised, placebo-controlled clinical study, based on the US FDA feedback
Moderna will conduct Phase 3 study of mRNA vaccine against Covid-19. (Credit: Belova59 from Pixabay.)
Moderna, a clinical-stage biotechnology company focused mRNA vaccines, has unveiled plans to advance the development of mRNA-1273, its mRNA vaccine candidate against Covid-19.
mRNA-1273 works against the Covid-19 encoding for a prefusion stabilised form of the spike (S) protein, selected by the company in partnership with Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Moderna chief medical officer Tal Zaks said: “We look forward to beginning our Phase 3 study of mRNA-1273 with some 30,000 participants in July.
“Moderna is committed to advancing the clinical development of mRNA-1273 as safely and quickly as possible to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease.”
Moderna will enrol around 30,000 participants in the Phase 3 study of mRNA-1273
Moderna has finalised a protocol for the Phase 3 randomised, placebo-controlled clinical study, based on the US Food and Drug Administration (FDA) feedback.
The study is planned to be conducted in collaboration with NIAID and enrol approximately 30,000 participants in the US.
The primary endpoint of the trial includes prevention of symptomatic Covid-19 disease, and key secondary endpoints include prevention of severe Covid-19 disease, as defined by the need for hospitalisation, and prevention of infection by SARS-CoV-2.
An event-driven analysis based on the number of participants with symptomatic Covid-19 disease will be the primary efficacy analysis.
Moderna has chosen 100μg dose level as the optimal dose level, based on the results of the Phase 1 study, to maximise the immune response while minimising adverse reactions.
Also, the company has completed the manufacture of adequate vaccine to begin the Phase 3 clinical trial and intends to dose the first patient in Phase 3 study in July 2020.
Funding from the biomedical advanced research and development authority (BARDA) has partially supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273 along with the manufacturing process and scale-up of mRNA-1273.
Moderna will also fund for the development of mRNA-1273 including portions of the Phase 3 study and the scale-up of manufacturing capacity to obtain licensure for mRNA-1273.