UC hosting Phase 3 clinical trial for ‘front-runner’ COVID-19 vaccine

UC hosting Phase 3 clinical trial for ‘front-runner’ COVID-19 vaccine

CINCINNATI (FOX19) - The University of Cincinnati and UC Health will soon host a Phase 3 clinical trial for a front-running COVID-19 vaccine, according to a university release issued Wednesday.

The vaccine was developed by scientists at the National Institute of Allergy and Infectious Diseases and collaborators at Moderna.

The third phase of the trial will provide data about how well the Moderna vaccine, mRNA-1273, actually protects people from the virus, the university says.

UC is one of 90 sites across the US selected for the study, which seeks to enroll more than 30,000 people in the clinical trial nationally.

Locally, UC plans to enroll 500 patients.

Those eligible include adults 18 and older with no known history of COVID-19 but who are at risk of becoming infected. Patients will receive the vaccine or a placebo and will be asked to keep a daily diary of their symptoms as well as participate in Telehealth and clinic visits with UC Health clinicians over a two-year period.

Screening is underway, UC says, and enrollment is expected to begin in July.

Carl Fichtenbaum, MD, professor in the Division of Infectious Diseases in the Department of Internal Medicine at the UC College of Medicine, is co-investigator of the UC study and will serve as medical director.

“UC was chosen because we have a proven track record of high-quality research and are the number-one site in the NIAID-funded, AIDS Clinical Trials Group in the US,” Fichtenbaum said. “We are proud to bring leading-edge research to Cincinnati so that we can help our community battle the COVID-19 pandemic and be part of the solution.”

Moderna CEO Stephane Bancel told CNBC in a recent interview he believes the vaccine has an 80-90 percent chance of receiving FDA approval.

In the same article, CNBC called the vaccine a “front-runner” candidate among the dozens currently in development and described its Phase 3 start date just three months following its creation “unheard of.”

UC cites previous studies that have shown the vaccine “elicits an immune response similar to individuals who have recovered from COVID-19.”

“The Moderna vaccine is a leading-edge technology using a genetic code to produce proteins like those seen with infection with COVID-19, allowing the body to respond,” Fichtenbaum added. “The hope is that the ongoing production of these proteins will generate antibodies that will protect against infection.”

UC’s release explains:

“Unlike conventional vaccines, which often use a small amount of live virus or antigen to stimulate an immune response, messenger RNA (mRNA) vaccines communicate with the body’s cells in a way that directs the cell to produce proteins.

“In the case of this COVID-19 mRNA vaccine, the protein that is made is similar to one that is normally made by the virus during an infection. This allows the body’s immune system to be stimulated and respond in a way that is protective, without being exposed to the actual virus.”

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