Moderna to begin testing its COVID-19 vaccine in 30,000 people starting in July
pharmafile | June 12, 2020 | News story | Medical Communications | COVID-19, coronavirus
Moderna is to start testing 30,000 people with its coronavirus vaccine beginning in July, after progressing through various trials.
The company has finalized the Phase 3 clinical trial structure for its COVID-19 vaccine, Mrna-1273, after dosing its first patient back on 16 March in its Phase I trial.
This Phase 3 trial will enroll 30,000 participants across the US and will be randomized in a 1:1 ratio in which patients will receive the vaccine or a placebo. The trial’s endpoint will be aiming to prevent the symptoms of the virus with the secondary endpoint being the prevention of infection.
The mRNA vaccine encodes a prefusion stablised form of the spike protein, and is a new type of technology where the vaccine contains a section of messenger RNA that codes for a protein associated with the virus. The body’s immune system reacts to the vaccine and develops an immune response to COVID-19.
Tal Zaks, Moderna’s Chief Medical Officer, said: “We look forward to beginning our Phase III 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.”
A Phase 2 trial is currently underway with healthy adults between the ages of 18 and 54, with the first patients receiving their dose 13 day ago, with the second one coming after 28 days. This trial is looking at the safety and immunogenicity of the vaccine and plans to enrol 600 overall people.
Conor Kavanagh
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