A COVID-19 vaccine candidate is moving to a Phase 3 trial of 30,000 components that begins today, and Brigham and Women’s Hospital will play two key roles in the next phase of the trial. The PHASE 3 COVE exam will compare mSAR-1273, a candidate vaccine for COVID-19 manufactured through Moderna, Inc. of Cambridge, Massachusetts. The exam will recruit component participants from across the United States, and Brigham will serve as clinical studies as a component of the COVID-19 Prevention Network (CoVPN), funded through the National Institutes of Health. In addition, Lindsey Baden, MD, Brigham’s infectious disease specialist and an expert in the progression of viral disease vaccines, will serve as lead co-investigator for the exam.
This is the first Phase 3 trial to verify the effectiveness of a vaccine opposed to COVID-19, and we have worked diligently in industry, academia and government to pave the way for the launch of this trial temporarily and safely. Our purpose is not only to launch this vital trial, but also to expand a fast, high-quality procedure for long-term vaccine trials. “
Baden is an expert in the development of novel diagnostics and therapeutics for viral diseases that disproportionately affect high-risk patients. He is the director of the Center for Clinical Investigation at the Brigham and the director of Infectious Diseases at Dana-Farber Cancer Institute. In addition, he is the vaccine clinical research site leader at the Brigham of the NIAID-funded Harvard HIV Vaccine Clinical Trials Unit and the program director for the Hub and Network elements of Harvard Catalyst (CTSA Award) at Harvard Medical School.
For 20 years, Brigham, led through Baden, has been a component of the HIV Vaccine Trials Network (HVTN), a global network of sites funded through the National Institutes of Health (NIH) that conduct clinical studies similar to the progression of HIV vaccines. Earlier this year, the NIH decided that several NIH-funded clinical trial networks, in addition to HVTN, would meet to answer vital questions about infectious diseases similar to COVID-19 under NVPV. Brigham, as well as clinical study sites in the United States, have been part of this network. The sites for vaccine studies were decided through an NIH mechanism and, through CoVPN control, it was decided that Baden should be the lead co-investigator of the upcoming Phase 3 mNS vaccine trial based on his clinical studies and the wisdom of COVID-19. Additional phase 3 vaccine trials are planned through COVPN in collaboration with pharmaceutical companies.
The COVE test is a component of Operation Warp Speed (OWS), which aims to administer three hundred million doses of an effective COVID-19 vaccine in early 2021. OWS represents a component among the factors of the Health and Human Services Decompotor, adding the Centers for Disease Control and Prevention, the FDA, NIH, BARDA and the Defense Decompose. The COVE study is largely funded by the U.S. government. Through the Advanced Biomedical Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases.
The COVE test is designed to primarily evaluate the efficacy and protection of mSA-1273 and its ability to save COVID-19 disease; participants will be followed up to two years after the dose of the vaccine at the time. The trial is expected to recruit 30,000 participants who will be randomly assigned to obtain two injections of one hundred micrograms (mcg) of mRN-1273 or two injections of a saline placebo. Trial volunteers will receive two intramuscular injections with a difference of approximately 28 days. The trial is blind, so researchers and participants won’t know who is assigned to which group.
Volunteers must give informed consent to participate in the trial. They will be asked to provide a nasopharyngeal pattern and blood pattern, a first test, and more blood patterns at specific times after each vaccination and within two years of vaccination. Scientists will read about blood patterns in the lab to find and quantify immune responses to SARS-CoV-2.
Researchers will largely monitor participant protection.
The target population of this study is adults whose location or cases put them at a significant threat of exposure to COVID-19. The number one endpoint will be the prevention of coVID-19 symptomatic disease. Key secondary assessment criteria come with the prevention of serious diseases in COVID-19 (as explained through the need for hospitalization) and the prevention of infection with the virus that causes COVID-19, SARS-CoV-2. An initial report on knowledge of the phase 1 mSR-1273 trial recently published in the New England Journal of Medicine, which found evidence that the vaccine induces an anti-SARS-CoV-2 immune reaction in the forty-five participants.
Hospital Brigham and Women’s
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