UCHealth Opens Clinical Trial For New Novavax COVID Vaccine Candidate
AURORA, Colo. (CBS4) - UCHealth is recruiting volunteers to participate in another large COVID-19 vaccine trial, the third underway at UCHealth locations. This new vaccine candidate has been developed by the Maryland-based, biotechnology company Novavax.
The vaccine uses tried-and-true technology, and in this phase 3 clinical trial, you have a better chance of getting the actual vaccine.
The Pfizer and Moderna vaccines, already in use, use new technology called messenger RNA (mRNA). They must be frozen and Pfizer's shot needs ultra-low temperatures.
Novavax uses a harmless, lab-made version of the coronavirus spike protein and adds an immune-boosting chemical. It only needs ordinary refrigeration. It is technology that has been used for some seasonal flu shots, HPV and HepB vaccines.
"It's important that we have alternatives to the mRNA technology," said Dr. Thomas Campbell, UCHealth Chief Clinical Research Officer and an infectious disease physician at the CU School of Medicine.
"We know from rolling out the Pfizer vaccine that there are some people who have some serious allergic reactions to it."
UCHealth is one of 115 sites in the US and Mexico. The goal is to enroll 30,000 volunteers overall.
According to UCHealth, the emphasis of the Novavax phase 3 trial is on demonstrating safety and effectiveness of the vaccine in people who are most at-risk for contracting and becoming ill from COVID-19.
UCHealth will also recruit individuals in higher-risk groups including Black, American Indian, Alaska native and Hispanic study participants as well as those with certain health conditions, including those older than 65 years old and people suffering from diabetes, obesity, heart disease, lung disease, or chronic kidney disease.
"The people we don't want to enroll are people who are next in line for getting a vaccination," Campbell told CBS4 Health specialist Kathy Walsh.
But Campbell encouraged individuals further down the list to sign up.
"They could get it sooner by being in study," he said.
The Novavax vaccine is two doses, three weeks apart and there is an incentive. While the study is randomized and placebo-controlled, 2/3 of participants will be given vaccine, just 1/3 placebo.
Reports are the Novavax vaccine produced robust antibodies without dangerous side effects in early clinical trials. Some say Novavax could have enough data to apply for emergency use in March.
Potential participants will be contacted through UCHealth's My Health Connection patient portal and invited to participate if they meet the criteria for the trial. Anyone who is interested in participating can also send an email to suzanne.fiorillo@cuanschutz.edu.
