American biotechnology company and one of the front runners in the COVID-19 vaccine drive, Moderna Inc is expected to start Phase 3 clinical trial for its vaccine candidate on or around July 27.
The firm which listed for the phase 3 study at the clinical trials website, began its Phase 1 trial just 66 days after scientists first decoded the genome of SARS-CoV-2. The initial results of Phase 1 which exhibited “promising” safety and immune response results were revealed on May 18
In a peer-reviewed paper on Nejm early this week, researchers, led by Dr. Lisa Jackson, asserted: “After the first vaccination, antibody responses were higher with the higher dose.”
Phase 1 Trial results
Moderna’s Phase 1 vaccine candidate trial was conducted among 45 healthy adults between ages 18 to 55 with all of them receiving two vaccinations o the medication, 28 days apart, with mRNA-1273 in a dose of 25 μg (micrograms), 100 μg, or 250 μg.
Participants divided into groups of 15 showed increased immune response through titers test results after the second vaccination.
On its public revelation of details on clinical trial numbered NCT04283461 for mRNA-1273, the team that the vaccine produced anti–SARS-CoV-2 or novel coronavirus immune responses in all participants with “no trial-limiting safety concerns”.
Phase 3 trials of mRNA-1273
Moderna is expected to conduct a US-based Phase 3 trials at 87 study locations. The experimental vaccine will be tested in 30 states and Washington, D.C. with close to half of the trials being conducted at severely affected regions like Arizona, California, Florid, Georgia, North and South Carolina and Texas.
The US federal government is supporting Moderna’s vaccine project with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials.