Brigham to play two key roles in phase 3 trial of COVID-19 vaccine candidate

A vaccine candidate for preventing COVID-19 is advancing to a 30,000-participant phase 3 trial that begins today, and Brigham and Women's Hospital will play two key roles in the trial's next phase. The phase 3 COVE study will evaluate mRNA-1273, a vaccine candidate against COVID-19 manufactured by Moderna, Inc., of Cambridge, Mass. The study will enroll participants at locations throughout the United States, with the Brigham serving as a clinical research site as part of the COVID-19 Prevention Network (CoVPN), funded by the National Institutes of Health. In addition, Lindsey Baden, MD, an infectious diseases specialist at the Brigham and an expert in vaccine development for viral diseases, will serve as co-principal investigator for the study.

This is the first phase 3 trial that will test the effectiveness of a vaccine against COVID-19, and we've been working diligently across industry, academia and government to pave a path for launching this trial rapidly and safely. Our goal has been to not only launch this important trial, but also to develop a rapid, high-quality process for vaccine trials that are to come."

Lindsey Baden, MD, Infectious Diseases Specialist, Brigham and Women's Hospital

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, the Brigham, under Baden's leadership, has been part of the HIV Vaccine Trials Network (HVTN), a National Institutes of Health (NIH)-funded global network of sites conducting clinical studies related to HIV vaccine development. Earlier this year, the NIH determined that several NIH-funded clinical trials networks, including the HVTN, would come together to answer important infectious disease questions related to COVID-19 under the CoVPN. The Brigham, along with clinical research study sites across the United States, became part of this network. Sites for the vaccine studies were selected through an NIH mechanism and Baden was chosen by the leadership of the CoVPN to be co-principal investigator of the upcoming mRNA phase 3 vaccine trial based upon his clinical research experience and his knowledge of COVID-19. Additional phase 3 vaccine trials are being planned by the COVPN in conjunction with pharmaceutical companies.

The COVE study is part of Operation Warp Speed (OWS), which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by early 2021. OWS represents a partnership among components of the Department of Health and Human Services, including the Centers for Disease Control and Prevention, the FDA, the NIH, BARDA, and the Department of Defense. The COVE study is largely funded by the U.S. government through the Biomedical Advanced Research and Development Authority (BARDA) and National Institute of Allergy and Infectious Diseases.

The COVE study is designed to primarily evaluate the effectiveness and safety of mRNA-1273 and its ability to prevent COVID-19 illness; participants will be followed for up to two years after the second dose of the vaccine. The trial is expected to enroll 30,000 participants who will be randomized to receive either two 100 microgram (mcg) injections of mRNA-1273 or two shots of a saline placebo. Trial volunteers will receive two intramuscular injections approximately 28 days apart. The trial is blinded, so the investigators and the participants will not know who is assigned to which group.

Volunteers must provide informed consent to participate in the trial. They will be asked to provide a nasopharyngeal swab and a blood sample at an initial screening visit and additional blood samples at specified time points after each vaccination and over the two years following the second vaccination. Scientists will examine blood samples in the laboratory to detect and quantify immune responses to SARS-CoV-2.

Investigators will closely monitor participant safety.

The target population for this study are adults whose locations or circumstances put them at appreciable risk of exposure to COVID-19. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by the virus that causes COVID-19, SARS-CoV-2. A preliminary report on data from the phase 1 trial of mRNA-1273 was recently published in the New England Journal of Medicine, which found evidence that the vaccine induced an anti-SARS-CoV-2 immune response in all 45 participants.

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