University of Minnesota Medical School launches COVID-19 vaccine trial
Enrolling volunteers for phase 3 study of NVX-CoV2373 vaccine
MINNEAPOLIS/ST. PAUL- Jan. 13, 2021 — The University of Minnesota Medical School announced today its plans to participate in a Phase 3 COVID-19 clinical trial in the fight against the novel coronavirus. The clinical trial will test the safety and effectiveness of an investigational vaccine developed by U.S. biotechnology company Novavax, Inc., called NVX-CoV2373. Novavax is a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases.
“We are pleased to be working with Novavax and the National Institutes of Health’s COVID Vaccine Prevention Network to conduct this Phase 3 trial in Minnesota,” said Susan Kline, MD, MPH, professor in the division of infectious diseases and international medicine at the University of Minnesota Medical School and the trial’s principal investigator. “We are eager to participate in seeking a path away from the impact of this pandemic by enrolling up to 500 participants in this trial.”
The clinical trial will take place through the University of Minnesota’s clinical research units, enrolling participants over the next two to three months with follow-up over the next two years.
The Phase 3 clinical trial design is harmonized with those of other leading companies and calls for the enrollment of up to 30,000 participants in the U.S. and Mexico. This clinical trial expects to include proportional representation among diverse populations most vulnerable to COVID-19 — distributed across race/ethnicity, age and those living with co-morbidities. Participants will randomly receive either the vaccine or placebo in two doses, 21 days apart. Two-thirds of volunteers will receive the vaccine and one-third will receive the placebo.
“This pivotal Phase 3 clinical trial in the U.S. and Mexico is critical to building on the encouraging safety and immunogenicity data we’ve generated to-date and ultimately demonstrating how well NVX-CoV2373 works to prevent COVID-19,” said Gregory M. Glenn, MD, President of R&D, Novavax. “We are grateful to the thousands of volunteers who are stepping forward to participate in this vital research.”
To learn more about the clinical trial and to determine eligibility, please visit https://covidvaccinenova.umn.edu.
Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, is a stable, prefusion protein. NVX‑CoV2373 is engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. It does not contain viral material and cannot replicate.
About the University of Minnesota Medical School
The University of Minnesota Medical School is at the forefront of learning and discovery, transforming medical care and educating the next generation of physicians. Our graduates and faculty produce high-impact biomedical research and advance the practice of medicine. Visit med.umn.edu to learn how the University of Minnesota is innovating all aspects of medicine.
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