UNMC participating in COVID-19 vaccine study

UNMC and Nebraska Medicine are involved in a national clinical trial to test the safety and effectiveness of an investigational COVID-19 vaccine for adults. The medical center plans to enroll up to 1,000 study participants.

Diana Florescu, MD

For this clinical trial, the medical center is working with the COVID-19 Prevention Network (CoVPN), formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health to respond to the pandemic. Thousands of study participants have been enrolled across several large studies to test several possible SARS-CoV-2 vaccines.

The investigational vaccine used for this clinical trial was developed by Novavax, Inc., a U.S. biotechnology company, which plans to enroll 30,000 adults in the U.S. and Mexico.

Novavax’ COVID-19 vaccine candidate is a protein based-vaccine created from the coronavirus spike (S) protein and an added component that boosts a person’s immune response to stimulate higher levels of antibodies.

Diana Florescu, MD, professor and infectious diseases specialist in the UNMC Department of Internal Medicine, is leading the Phase 3 clinical trial at UNMC.

“We are grateful and excited that UNMC was chosen as a site for this important work,” Dr. Florescu said. “We hope that this SARS-CoV-2 vaccine will prevent people from developing severe COVID-19 disease. We also will be watching to see if the vaccine reduces the severity of COVID-19 illness, decreasing the chances of being hospitalized or even death among those that get the infection.”

Two out of every three people will get the investigational vaccine and one out of every three will receive a placebo, meaning it will not contain vaccine. “This vaccine does not contain live or inactivated virus so it does not cause infection,” Dr. Florescu said.

The investigational vaccine requires two shots given three weeks apart. Four additional follow-up visits are required during the first year and two during the second year.

“We encourage individuals who won’t be receiving the Pfizer or Moderna vaccines in the next three to six months to consider enrolling in the clinical trial. Participants in the Novavax vaccine clinical trial can remain in the trial and also receive the Pfizer or Moderna vaccine when it is available to them,” Dr. Florescu said.

The clinical trial is looking for people who:

• Are 19 years of age and older, including adults over age 65, including those with chronic or long-term health conditions;
• Have not had COVID-19;
• Are not pregnant, breastfeeding or planning to become pregnant over the next four months; and
• Are at increased risk for exposure to SARS-CoV-2 infection, including people who work in essential jobs and people who have other medical conditions and co-morbidities (i.e., people living with HIV).

For more information about the clinical trial or enrolling, go to this website and complete the questionnaire to be contacted by a study member.

See more information about the vaccine trial (IRB# 727-20-CB).