KINGSPORT — Holston Medical Group announced on Monday its clinical research units in Kingsport and Bristol, Tennessee, will participate as study sites and begin enrolling participants into a global study for a vaccine for the virus causing the current pandemic.
The Phase 2/3 global study is sponsored by Pfizer Inc. and BioNTech.
The Holston Medical Group study site is one of more than 120 clinical investigational sites around the world that will collectively enroll up to 30,000 participants.
“We are excited to be working on this clinical trial at both our Bristol, Tennessee, and Kingsport, Tennessee, sites,” Dr. David Morin, director of Research at HMG said. “Clinical research plays a vital role in our ability to move forward past these unprecedented times and our goal is to find a safe and effective vaccine for the prevention of COVID-19.”
About the Phase 2/3 Study
The Phase 2/3 study is an event driven trial that will enroll up to 30,000 participants at more than 120 clinical investigational sites around the world, in non-pregnant adults 18-85 years old.
The Phase 2/3 trial is designed as a 1:1 investigational vaccine candidate to placebo, randomized, observer-blinded study to obtain safety, immune response and efficacy data needed for regulatory review. The trial’s primary endpoints will be prevention of COVID-19 in those who have not been infected by SARS-CoV-2 prior to immunization, and prevention of COVID-19 regardless of whether participants have previously been infected by SARS-CoV-2. Secondary endpoints include prevention of severe COVID-19 in those groups.