GW to participate in a clinical trial for investigational COVID-19 vaccine

The George Washington University (GW) today announced that it will participate in a clinical trial for an investigational COVID-19 vaccine. GW has been selected as one of approximately 90 sites in the United States to participate in clinical trials of experimental vaccines and monoclonal antibodies as part of the COVID-19 Prevention Network (CoVPN), established by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). Scientists hope the trials will result in new tools to prevent COVID-19, the disease caused by the novel coronavirus that has killed over 600,000 worldwide, including more than 140,000 Americans.

Led by David Diemert, MD, professor of medicine at the GW School of Medicine and Health Sciences (SMHS) and a physician in the Division of Infectious Diseases at The GW Medical Faculty Associates (MFA), researchers at GW Milken Institute School of Public Health (Milken Institute SPH), GW SMHS, and the GW MFA will participate as a trial site in a Phase 3 clinical trial of the mRNA-1273 vaccine, co-developed by NIAID scientists and the biotechnology company Moderna, Inc.

The vaccine uses a chemical messenger called ribonucleic acid or RNA that instructs the body's cells to create a protein that mimics one found on the outer surface of the virus that causes COVID-19. The hope is the injections will spur the body to mount an immune response that will protect against the novel coronavirus. The trial is the latest advance in a series of steps to test the vaccine's safety and efficacy in humans.

COVID-19 is one of the greatest public health challenges of our time, and it is of utmost importance to find a safe and effective vaccine. We are proud to play a role in the network of researchers working to reduce the impact of this deadly disease."

David Diemert, MD, principal investigator of the clinical trial at GW

The researchers aim to enroll 500 participants in the clinical trial at GW out of 30,000 volunteers nationwide. The participants must be at least 18 years old, and at least one-quarter will be 65 or older, or younger than 65 but have at least one comorbidity like heart disease, severe obesity or diabetes. The reason for these parameters is to test the effectiveness of the vaccine among populations who are currently at high risk for experiencing severe illness or death if they contract the novel coronavirus. The researchers also hope to include a diverse group of participants from communities that have been disproportionately impacted by COVID-19.

The participants will receive two injections, spaced one month apart. As a control measure, half of the enrollees will receive a saline placebo. All participants will be monitored for symptoms, side effects, and COVID-19. Researchers will follow up regularly with participants for two years after the second dose of the vaccine.

Clinical activities will be directed by infectious disease specialists at the GW MFA.

"This groundbreaking study offers a significant hope that there will be an effective vaccine in the near future, and it speaks to GW's research preeminence that our infectious diseases group has been selected to participate in this groundbreaking trial. Both Dr. Diemert and I along with the entire infectious disease faculty are looking forward to the successful enrollment of this trial here," said Marc Siegel, MD, associate professor of medicine at GW SMHS and a physician in the Division of Infectious Diseases at the GW MFA.

The study will be conducted in partnership with Milken Institute SPH and the NIH-funded GW HIV Prevention Trials Network clinical research site, led by Manya Magnus, PhD, MPH, a professor of epidemiology at Milken Institute SPH.

"Local engagement in these trials is critical. We will work closely with the community, especially those disproportionately affected by COVID-19, to help create this vaccine," said Magnus, who is a co-investigator on the trial and who will support recruitment and data quality efforts with Milken Institute SPH researchers. "Diversity and inclusivity in this study are key to developing a vaccine that will be safe and effective for all."

The CoVPN was established as part of the federal effort to develop a safe, effective vaccine for COVID-19. The CoVPN merges four existing NIAID-funded clinical trials networks: the HIV Vaccine Trials Network, the HIV Prevention Trials Network, the Infectious Diseases Clinical Research Consortium, and the AIDS Clinical Trials Group.

For more information on the CoVPN or to screen for eligibility to participate in the trial, visit coronaviruspreventionnetwork.org/.