press-release August 7, 2020
Wake Forest Baptist Health and Javara Begin Recruiting Healthy Adults for COVID-19 Vaccine Clinical Trial
WINSTON-SALEM, N.C. – Aug. 7, 2020 – Wake Forest Baptist Health, in partnership with Javara, announced today they have begun recruiting healthy adults for a Phase 3 clinical research study to evaluate the safety and effectiveness of mRNA-1273, a vaccine candidate against COVID-19. Sponsored by Moderna, the COVE Study is recruiting healthy volunteers ages 18 or older in high-risk populations, including the elderly, racial and ethnic minorities at higher risk for COVID-19, and essential workers in close contact with potentially infected persons.
The Phase 3 study will evaluate if mRNA-1273 boosts the immune system to produce enough antibodies against SARS-CoV-2, the virus that causes COVID-19, so it does not cause illness in case of infection.
“We are excited and hopeful as we begin participating in the COVE Study, understanding this is one of the most important and impactful clinical research studies in our lifetime,” said John Sanders, M.D., chief of infectious diseases and principal investigator, Wake Forest Baptist Health. “We encourage individuals across the Winston-Salem area to consider participating in this trial, which could bring the world one step closer to ending this global health crisis.”
To be eligible for the study, healthy volunteers must be 18 years of age and older with no known history of SARS-CoV-2 infection or previous participation in an investigational coronavirus vaccine. Within this population, Wake Forest Baptist Health and Javara are prioritizing candidates whose locations or circumstances put them at higher risk of exposure to the virus, including:
- Elderly, ages 65 and older
- Essential workers in close contact with potentially infected persons, including, but not limited to, healthcare and hospital workers, first responders, transit employees, institutional residents or workers, factory employees, and teachers and students
- Racial and ethnic minorities at high risk for COVID-19
If a person is eligible and decides to participate, the research staff at Wake Forest Baptist Health and in partnership with Javara will randomize patients to receive either the mRNA-1273 vaccine or a matching placebo. The total length of participation is 25 months and includes approximately seven visits to the clinic and 24 phone calls.
Wake Forest Baptist Health is one of 89 research sites across the country participating in the COVE Study. If someone is interested in participating in clinical research in their area, they can call 336-713-7888 or email email@example.com to learn more.
Wake Forest Baptist Health: Joe McCloskey, firstname.lastname@example.org, 336-716-1273
Javara: Amanda Wright, email@example.com
Wake Forest Baptist Health (www.wakehealth.edu) is a pre-eminent academic health system based in Winston-Salem, North Carolina. Wake Forest Baptist’s two main components are an integrated clinical system – anchored by Wake Forest Baptist Medical Center, an 885-bed tertiary-care hospital in Winston-Salem – that includes Brenner Children’s Hospital, five community hospitals, more than 300 primary and specialty care locations and more than 2,500 physicians; and Wake Forest School of Medicine, a recognized leader in experiential medical education and groundbreaking research that includes Wake Forest Innovations, a commercialization enterprise focused on advancing health care through new medical technologies and biomedical discovery. Wake Forest Baptist provided a record-setting $580.8 million in community benefits during the 2019 fiscal year, including unreimbursed care, charity care, education and research, and community health improvement. Follow us on Facebook, Twitter and Instagram.
Javara is a Winston-Salem, N.C., based Integrated Research Organization (IRO) driven to change the clinical research experience and expand access to clinical trials – for both providers and patients. The Javara team includes experienced clinical research leaders who have collectively led over 10,000 trials and engaged more than 200,000 people in clinical trials. More information about Javara is at www.Javararesearch.com.
Javara is the leading Integrated Research Organization (IRO) partnering with large healthcare organizations in local communities across the US to integrate clinical research into clinical care. Our access to broad diverse patient populations through their trusted physicians ensures clinical trials are completed with high enrollment and retention for quality data delivery. Javara’s centralized resources and standardized operations provide efficiencies for accelerated study start-up and quality outcomes, so fewer obstacles stand in the way of the product approval process. Our team includes experienced clinical research leaders who have collectively led 10,000+ trials and engaged 200,000+ patients in clinical trials. As pioneers of Clinical Research as a Care Option (CRAACO), Javara is transforming healthcare and changing lives by connecting the right patients to the right trials at the right time. For more information, please visit Javararesearch.com.
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