New York: Moderna Inc said on Tuesday it plans to start a late stage clinical trial for its COVID-19 vaccine candidate on or around July 27, according to its listing for the phase 3 study at clinicaltrials.gov.
Moderna began its Phase 1 trial just 66 days after scientists first decoded the genome of SARS-CoV-2. Initial results of Phase 1 was announced on May 18, in which the vaccine showed "promising" safety and immune response results.
Nejm published the peer-reviewed paper on July 14, 2020. The researchers, led by Dr Lisa Jackson, stated: "After the first vaccination, antibody responses were higher with higher dose."
Phase 1 study results
The team conducted Phase 1, as a dose-escalation, open-label trial including 45 healthy adults (ages 18 to 55).
They received two vaccinations, 28 days apart, with mRNA-1273 in a dose of 25 μg (micrograms), 100 μg, or 250 μg.
There were 15 participants in each dose group. After the second vaccination, the titers increased (indication of immune response).
The team concluded that the mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants, and that "no trial-limiting safety concerns were identified". The study was funded by the National Institute of Allergy and Infectious Diseases and others, with details publis on mRNA-1273 on ClinicalTrials.gov number, NCT04283461.
Moderna Inc said on Tuesday (July 14) it plans to start a late stage clinical trial for its COVID-19 vaccine candidate on or around July 27, according to its listing for the Phase 3 study at clinicaltrials.gov.
87 study locations for Phase 3 trials of mRMA-1273
Moderna said it will conduct the trial at 87 study locations, all in the United States.
The experimental vaccine will be tested in 30 states and Washington, D.C. Around half of the study locations are in hard-hit states like Texas, California, Florida, Georgia, Arizona and North and South Carolina.
The United States has reported record numbers of new coronavirus cases in recent days, with much of the surge coming from those states.
The 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.
Tensions between the company and government scientists contributed to a delay of the trial launch, Reuters reported earlier this month.