Two Wilmington companies are supporting a phase 3 clinical study aimed at developing a vaccine for the new coronavirus.
Wilmington-based PPD Inc. is one of those companies involved in Moderna Inc.'s phase 3 study of its mRNA vaccine candidate against COVID-19, according to a news release.
Cambridge, Massachusetts-based Moderna Inc. and the National Institute of Allergy and Infection Diseases (NIAID), part of the National Institutes of Health, announced this week that the phase 3 trial for the vaccine, known as mRNA-1273, has started.
NIAID and the federal government's Biomedical Advanced Research and Development Authority (BARDA) are providing funding for the trial, stated the release.
The biotechnology company is working with the NIAID and BARDA to develop the study, which is being supported by the government's Operation Warp Speed, a multi-agency initiative consisting of private and public partners that aims to deliver a safe and effective vaccine for COVID-19 by January 2021.
“Congratulations to Moderna on this important milestone. The world is eager for solutions, and we are pleased to support Moderna in progressing its vaccine candidate," David Simmons, PPD’s chairman and CEO, said this week. "The depth of our relationship with Moderna has enabled us to jointly expedite strategy development from the early days of the pandemic and accelerate its COVID-19 program execution.”
On top of PPD's work to support Moderna's phase 3 study, it has also supported the phase 2 study, which completed the enrollment of 600 people at eight research sites within a month, according to the release.
"PPD has contributed an array of clinical development and laboratory services, including strategic expertise to the study design, patient-enrollment epidemiology modeling and biostatistics," stated the release.
The phase 3 trial is expected to include 30,000 participants and take place at 100 clinical research sites selected by Moderna, according to the release.
"The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology. SARS-CoV-2 is the virus that causes COVID-19," stated the release.
Moderna "is partnering closely with those sites to ensure that volunteers at increased risk for COVID-19 disease are enrolled in the study" and is working with local communities to reach a diverse population, officials said in the release.
Wilmington is one of those sites, said Phil Dattilo, president of Wilmington-based Trial Management Associates LLC, a clinical management firm.
Trial Management Associates (TMA) is taking part in Moderna's phase 3 study by working with Bart Williams and Will Jones, two physicians at Wrightsville Family Practice, to conduct phase 3 clinical trials in Wilmington.
The company announced in June that it would be part of a phase 3 trial
for a potential coronavirus vaccine, but was unable at the time to confirm what the firm it was involved with.
“Drs. Williams and Jones are very excited to begin the Phase 3 trial of Moderna’s vaccine here in Wilmington this coming week,” Dattilo said in an email Thursday. “We are continuing to accept people who are interested in participating … We appreciate all of our current volunteers’ patience as we work diligently to schedule the large volume of volunteers for their initial visit.”
Those in the area who would like to participate in the phase 3 trial can email TMA at [email protected]
The group was also selected by Moderna earlier this year to conduct a phase 2 trial for the potential vaccine. Wilmington was one of 10 sites selected by Moderna for the phase 2 trial, which wrapped up earlier this year.
Another company, Pfizer, announced Monday that it had also begun a late-stage coronavirus vaccine study, according to news reports