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Coronavirus

Wilmington One Of 10 Sites Selected For Second Phase Of Coronavirus Vaccine Trials

By Christina Haley O'Neal, posted Jun 19, 2020
A Wilmington-based clinical research management company and a local family practice have been selected for the second phase of a coronavirus vaccine trial, which could help fight COVID-19, according to a news release.

Cambridge, Massachusetts-based Moderna Inc. selected Trial Management Associates LLC (TMA) and Wrightsville Family Practice for the phase two trial of its mRNA-1273 SARS-CoV-2 vaccine, stated the release.

Wilmington is one of 10 sites for the trials nationwide.

SARS-CoV-2 stands for severe acute respiratory syndrome coronavirus 2, according to the World Health Organization. It's the virus that causes the disease COVID-19. 

"TMA and Wrightsville Family Practice are recruiting study volunteers ages 18 and older from Wilmington and the surrounding communities to participate in the trial," officials said in the release.

"TMA, Dr. Bart Williams and Dr. Will Jones are excited and humbled by the opportunity to conduct such a critical trial for the global community. I foresee this being a major milestone for our company moving forward," said Phil Dattilo, president of TMA. "This trial has not only given us the opportunity to get involved in the fight against COVID-19, but it has also allowed our organization to grow, keep our folks working and hire new employees in very uncertain economic times." 

Wilmington-based TMA is a clinical research management company that partners with private physician practices to successfully manage and execute phase two through four industry-sponsored clinical research studies, stated the release.

Phase two of the study has already started and should be wrapping up in early July, Dattilo said.

Though it seems unlikely to be taking place in Wilmington, the third phase of the study is slated to begin in July.

For phase three, Moderna will seek some 30,000 study volunteers, and it appears the company will be targeting larger metropolitan areas with a higher prevalence of COVID-19 utilizing National Institutes of Health (NIH) and other research centers located in these areas, Dattilo said.

“That’s still to be determined. This is phase two of the study, and phase three is scheduled to start sometime in July. Then, the FDA has to approve the vaccine. I can tell you the development of this vaccine is moving very quickly, which should give us hope for a vaccine sooner rather than later,” he said.

Moderna's mRNA-1273 is "an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH."

“It’s a very special opportunity for the Wilmington community to be involved in the development of this much-needed vaccine,” said Dattilo. 

“TMA is hopeful we will have the opportunity to conduct more COVID-19 vaccine trials in the coming months," he said. "We are working extremely hard to secure additional COVID-19 vaccine trials to provide our community with the option to participate."  

The first clinical batch was completed Feb. 7, and underwent analytical testing, according to the release. It was shipped to NIH on Feb. 24, 42 days from sequence selection.

"The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing," stated the release.

TMA has received calls from as far as Rhode Island for volunteers who are willing to drive to Wilmington to participate, officials said.

"We are very excited to be a part of this clinical trial that has the potential to push us closer in the medical and scientific communities’ pursuit of an FDA-approved vaccine against SARS-CoV-2," Bart Williams, a physician and the principal investigator of the study, said.

As the research progresses into the larger trials, TMA will need more volunteers for the studies, according to the release.

“Dr. Bart Williams and Dr. Will Jones wanted to become involved in the global fight against the coronavirus pandemic. Through our collective experience, historical success and close partnerships with Chris Hoyle at Elite Research Network and the selected Contract Research Organization (CRO), we were able to secure this vital Phase II trial,” Dattilo said in the release.

"It's always our goal to be on the cutting edge of research and give our partners and the Wilmington community the ability to volunteer for these types of research trials," he said.

Correction: This version has been changed to correct the spelling of "coronavirus" in the headline.
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