Cindy Gay, MD, is leading the phase III clinical trial of the promising COVID-19 vaccine candidate for the UNC School of Medicine and UNC Medical Center. Gay also leads the UNC Moderna vaccine phase III clinical trial. (Update: these clinical trials are no longer enrolling participants.)
CHAPEL HILL, NC – UNC School of Medicine infectious diseases physicians and research staff are recruiting participants for a phase III clinical trial to test the safety and effectiveness of NVX-CoV2373, a COVID-19 vaccine candidate developed by U.S. biotechnology company Novavax, Inc.
Novavax’ clinical trial calls for the enrollment of up to 30,000 participants in the U.S. and Mexico across 100 sites. 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 in order to test how well the vaccine works. Participants will be followed for 24 months post-vaccination to monitor their health and safety. Each participant will be compensated for their participation.
This clinical trial expects to include proportional representation of diverse populations most vulnerable to COVID-19, including minorities, people above age 65, and those living with co-morbidities such as chronic and kidney lung disease, cardiac disease, severe obesity, diabetes or liver disease, as well as those with HIV. UNC aims to recruit 350 participants across its trial locations, which include the UNC Medical Center in Chapel Hill, and two additional sites in Chatham County.
“It is critical to continue our research on COVID-19 vaccines because we aren’t at the finish line yet,” said Cindy Gay, MD, principal investigator of UNC’s Novavax clinical trial site, associate professor in the Division of Infectious Diseases at the UNC School of Medicine, and member of the UNC Institute for Global Health and Infectious Diseases. “We need multiple options in order to be able to provide vaccines to people in the U.S. and across the globe in a timely manner. We still need our community to help by participating in these clinical trials so that we can make sure everyone who wants a vaccine will get one that is safe and effective.”
The Novavax clinical trial will prioritize the inclusion of Black and Latino participants, as those communities have experienced a disproportional impact from COVID-19.
“Every drug we take has to be tested in order for us to know that it’s going to work in our community,” said Craig Cameron, PhD, Chair of the UNC School of Medicine Department of Microbiology and Immunology and a COVID-19 vaccine trial participant. “We have to step up and contribute, otherwise we won’t necessarily have a vaccine that will have the right dose and safety for our community.”
Keisha Gibson, MD, Chief of the UNC School of Medicine’s Pediatric Nephrology Division and Vice Chair of Diversity and Inclusion in the Department of Medicine, is also participating in COVID-19 vaccine clinical trial. She understands the hesitancy of some community members to take part.
“It’s important to provide the education of all the steps we have employed to make sure people are protected moving forward,” Gibson said. “While we all understand where this distrust comes from – a very troubling history between communities of color and biomedical research – we also have to understand that if our response as a community is to disengage or not take part in these trials, we will always allow our communities to stay at a disadvantage.”
Janeth Pearl, a local resident who is part of the Latino community, said that as a nurse practitioner, she was not afraid of participating in a COVID-19 vaccine trial. She encourages others to volunteer for upcoming trials if they are able. “We have all been significantly affected by the pandemic,” Pearl said. “I think that everyone has the obligation, responsibility, and at the same time, the privilege, to contribute in any way we can. So, I invite you to come participate because our community still needs volunteers.”
To see if you are eligible to participate in UNC’s Novavax vaccine clinical trial, or other upcoming trials near you, go through the COVID-19 Prevention Network (COVPN) Volunteer Screening Registry. To learn more about all COVID-19-related clinical trials at UNC, visit the UNC COVID-19 Clinical Research website.
About Novavax Vaccine NVX-CoV2373
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.