The Vaccine and Treatment Evaluation Unit at Baylor College of Medicine has been selected as one of more than 100 sites to participate in the Phase 3 clinical trial to evaluate the safety and effectiveness of Novavax's COVID-19 vaccine candidate.
The trial is expected to enroll approximately 30,000 participants 18 years of age and older across the country and in Mexico, and Baylor aims to enroll approximately 250 participants.
Dr. Mary Healy, associate professor of pediatrics - infectious diseases at Baylor, and Dr. Jennifer Whitaker, assistant professor of molecular virology and microbiology and medicine - infectious diseases at Baylor, will serve as co-principal investigators of the Baylor site.
"Multiple effective vaccines will be needed to vaccinate everyone," Healy said. "One or two companies cannot make enough vaccine to take control of this pandemic."
The Novavax vaccine candidate, called NVX-CoV2373, is protein-based and includes an adjuvant to enhance the immune response.
"Additionally, we need vaccines that can reach everyone and do not have extreme cold temperature requirements for storage and distribution, which is one of the characteristics of this vaccine candidate," Whitaker said.
Two out of three people participating in the clinical trial will receive two intramuscular injections of the Novavax vaccine candidate spaced at three weeks apart. The investigational vaccine is designed to prevent COVID-19 by helping create neutralizing antibodies to fight COVID-19 infection. The remaining one-third of participants will receive injections of a placebo made of saline solution.
All participants will be randomly selected to receive either the vaccine candidate or the placebo. Participants will be followed for 24 months post-vaccination to monitor their health and safety.
Researchers are hoping to enroll volunteers 65 years and older, individuals with underlying medical conditions, and people of racial and ethnic groups that have been impacted in greater numbers by the pandemic, including members of the Black, Latinx, Asian American, Native American and Alaskan Native communities.
