Wilmington’s TMA and Wrightsville Family Practice selected as one of ten sites nationwide for Phase II trial of Moderna’s mRNA-1273 vaccine.
WILMINGTON, NC, (June 16, 2020)— Trial Management Associates, LLC (TMA), an integrated site network, and Drs. Bart Williams and Will Jones of Wrightsville Family Practice in Wilmington, NC, have been selected by ModernaTX, Inc., as one of ten sites nationwide to conduct the Phase II trial of its mRNA-1273 SARS-CoV-2 vaccine. TMA and Wrightsville Family Practice are recruiting study volunteers ages 18 and older from Wilmington and the surrounding communities to participate in the trial.
SARS-CoV-2 originated in Wuhan, Hubei Province, China, around December 2019 and has spread from China to over 200 countries and territories around the world. According to the Centers for Disease Control and Prevention (CDC), there have been 2,085,769 confirmed cases SARS-CoV-2 with 115,644 total deaths in the United States, as of June 16, 2020.
“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,” says Phil Dattilo, president of TMA. “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.”
Dr. Bart Williams, the Principal Investigator of the study, says, “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.”
About the mRNA-1273
According to Moderna, its 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. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020, and underwent analytical testing; it was shipped to NIH on February 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.
Study Volunteers Needed
The community’s response to the Phase II trial has been tremendous. TMA has received calls from as far as Rhode Island for volunteers who are willing to drive to Wilmington, NC, in order to participate. As the research progresses into the larger trials, TMA will need more volunteers for the studies. TMA is especially seeking healthy volunteers age 55 and over, healthcare workers and other personnel who are at higher risk of exposure to the SARS-CoV-2 coronavirus. If anyone in Wilmington, NC, and the surrounding communities would like more information or sign up to participate, please contact TMA at info@trialmgt.com.
For more information on the study, visit modernatx.com or clinicaltrials.gov.