coronavirus vaccine

UM School of Medicine to Launch Clinical Trials for Potential Coronavirus Vaccine

Volunteers sought to test coronavirus vaccine developed by Moderna, soon entering Phase 3 trial with 30,000 participants nationwide.

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The University of Miami's Miller School of Medicine will launch a testing site to run clinical trials on potential COVID-19 vaccines. (To register to volunteer, sign up here).

As a participant of the National Institutes of Health COVID-19 Prevention Trials Network, the Miller School plans to enroll 1,000 volunteers in South Florida in a clinical trial expected to start in the summer.

“The COVID-19 pandemic is having a tremendous impact in South Florida and across the world,” said Dr. Susanne Doblecki-Lewis, an infectious disease expert at the University of Miami who will lead the initiative. “We are testing vaccines with the goal of finding a safe and effective way to halt the spread of the virus.” 

The clinical trials will test a vaccine developed by National Institutes of Health scientists and their collaborators at the biotechnology company ModernaTX Inc.

Prospective volunteers for the study will need to be at least 18 years old. A news release said the school plans to use community outreach and mobile operations to recruit from a wide variety of demographics.

“We are committed to engaging people who represent the range of residents impacted by COVID-19 in South Florida by gender, age, race, and ethnicity, as well as those who are particularly at-risk because of medical conditions,” said Doblecki-Lewis. “This is how we will help ensure that any vaccine that is developed will be relevant for those who could benefit most from it.”

The Moderna vaccine performed well in a much smaller study of 45 participants reported Tuesday in a major medical journal, and other companies have also reported promising early results.

Side effects were minor for those who received the lowest dose, which is what the UM volunteers will receive, said Dr. Maria Alcaide, a co-investigator of the UM component of the study.

Participants are paid for their time and inconvenience during what is scheduled to be a three-month study.

"It's not for people who are infected. It's for people who are at risk," Alcaide said.

Participants will not be intentionally infected with the disease, but rather monitored to see if the vaccine causes them to produces antibodies that counter the virus and prevent COVID-19, the disease caused by the virus.

In addition to being a hot spot, with between 20-25% of tests coming back positive in Miami-Dade, the area's racial and ethic diversity makes it an attractive backdrop for the study.

Alcaide noted the disease disproportionately affects minorities in a negative way.

"We really want to reach out to all the communities that are at risk," she said, while noting that "is really everybody in Miami nowadays."

The final verdict on this vaccine and others will only come after months more testing, but Alcaide said "it's too early to know. It’s promising and we really are hoping it will work."

The news release said that the Miller School of Medicine is a major research center for infectious diseases, namely HIV and AIDS. "The University’s affiliation with the HIV Vaccine Trials Network made it a natural location to test COVID-19 vaccines," the release read.

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