A Phase 3 clinical trial designed to evaluate if an investigational vaccine can prevent COVID-19 in adults has begun in the United States, said a release of the National Institutes of Health (NIH) on Monday.
The vaccine, known as mRNA-1273, was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
The trial, which will be conducted at U.S. clinical research sites, is expected to enroll approximately 30,000 adult volunteers who do not have COVID-19, according to the release.
"Although face coverings, physical distancing and proper isolation and quarantine of infected individuals and contacts can help us mitigate SARS-CoV-2 spread, we urgently need a safe and effective preventive vaccine to ultimately control this pandemic," said NIAID Director Anthony Fauci.
"Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase 3 clinical trial. This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last," he said.
Moderna is leading the trial as the regulatory sponsor and is providing the investigational vaccine for the trial. The Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response and NIAID are providing funding support for the trial, according to the release.
"Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it's the right goal for the American people," said NIH Director Francis Collins.
"The launch of this Phase 3 trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal," he said.
The mRNA-1273 vaccine candidate will be tested at approximately 89 clinical research sites in the United States. Investigators will use public health data and incidence trajectory modeling to identify sustained high-incidence areas and emerging hot zones, so sites near these locations can be prioritized for enrollment.
NIAID scientists developed the stabilized SARS-CoV-2 spike immunogen (S-2P). Moderna's mRNA-1273 uses the mRNA (messenger RNA) delivery platform to encode for an S-2P immunogen.
The investigational vaccine directs the body's cells to express the spike protein to elicit a broad immune response, according to the release.
A Phase 1 clinical trial found the candidate vaccine to be safe, generally well-tolerated and able to induce antibodies with high levels of virus-neutralizing activity, said NIH. Moderna initiated Phase 2 testing of the vaccine in May 2020.
According to Fauci, the U.S. government will fund and conduct key studies on three experimental coronavirus vaccines. Besides the Phase 3 trial by Moderna in July, one for an Oxford/AstraZeneca vaccine will begin in August and one by Johnson & Johnson in September.
