Now Novavax: UI Health Care’s role in a new COVID-19 vaccine clinical trial

UI Health Care experts are again lending their expertise in clinical research to participate in a COVID-19 vaccine trial, this time a large, Phase 3 trial for a new COVID-19 vaccine made by Novavax, Inc.

The multi-site clinical trial—which aims to enroll 30,000 participants—will further validate the safety, tolerability, immunogenicity, and efficacy of the vaccine against COVID-19. The UI site started vaccinations on Jan. 4, 2021, and plans to enroll 250 participants. 

Two vaccines—made by Pfizer-BioNTech and Moderna—have already been authorized for emergency use by the FDA and are being used across the country. However, additional vaccines continue to be tested in Phase 3 clinical trials.

“Different types of vaccines are helpful because certain people might respond better to one type of vaccine than another,” says Patricia Winokur, MD, executive dean and principal investigator for the UI trial site for the Novavax vaccine. Winokur also led the UI site for the clinical trial of the Pfizer-BioNTech vaccine. 

How is the Novavax vaccine different?

Novavax uses a more traditional vaccine technology than the Pfizer-BioNTech and Moderna vaccines, which use mRNA to generate an immune response. The Novavax vaccine creates an immune response by injecting a piece of the outer coat of the SARS-CoV-2 virus—the spike protein— along with a compound that stimulates the immune system. Because the vaccine does not contain the whole virus, it cannot cause COVID-19. This so-called subunit vaccine is the same technology that has been used previously for seasonal flu shots. 

I think this is going be a really important trial because this vaccine can be stored at refrigerator temperatures, so if it’s safe and effective, this is going to be a much more appropriate vaccine for small practices and for other countries that don’t have the same infrastructure that the U.S. has.

The study is open to men and nonpregnant women over age 18. However, the researchers particularly want to recruit people over age 65; those who have medical conditions, like obesity, diabetes and high blood pressure, that put them at high risk for severe disease; underrepresented populations; and people with jobs that put them at increased risk for coming into contact with the virus, which might include younger essential workers 

As with the previous vaccine clinical trials, Winokur notes the importance of enrolling a diverse population to ensure that the vaccine is equally effective in people of different ages, races, and genders. 

Participants will receive two intramuscular doses of vaccine 21 days apart. Two thirds of participants will get the active vaccine and one third will get a placebo injection. Over 8-10 visits, the participants will be evaluated to learn about the safety and effectiveness of the vaccines as well as any side effects that might occur.  

All participants in the Novavax study will be followed for up to two years to see if they develop symptoms of COVID-19. The study will compare rates of COVID-19 infection between people getting active vaccine and those getting placebo.

Get more information on the Novavax vaccine