Vanderbilt University Medical Center (VUMC) is enrolling volunteers ages 12-69 to take part in an NIH funded study to assess reactions to the Pfizer and Moderna COVID-19 vaccines in highly allergic individuals.

The national study is a randomized controlled phase 2 clinical trial involving 30 sites to help determine the prevalence of systemic allergic reactions to the two-dose COVID-19 vaccines.

True allergies associated with these vaccines appear to be quite rare, in the range of only three to four cases per million doses administered, said VUMC's principal investigator Elizabeth Phillips, MD, an internationally known expert in drug hypersensitivity.

"Safety concerns have been cited in surveys by a significant number of people who say they are hesitant to be vaccinated. That's why studies like this are so important," said Phillips, professor of Medicine and Pharmacology and the John A. Oates Chair in Clinical Research at VUMC.

"We really have to provide widespread reassurance to get high rates of vaccination. If the virus is replicating in the community, it's going to mutate. The only way to shut that down and prevent severe illness and hospitalization is to get the population completely covered."

The trial is supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Phillips and her colleagues are seeking about 120 volunteers for the study at VUMC from the following groups:

• Healthy individuals 18 and older who have no history of severe allergic reactions and have not yet been vaccinated against COVID-19 but want to get the vaccine through their participation in the study; and

• People who are highly allergic to certain foods, drugs and other environmental triggers and who have had at least one episode of anaphylaxis requiring epinephrine injection in the past five years.

Study participants will be assigned randomly to receive a first dose of one of the two mRNA vaccines or inactive placebo. The placebo group will receive the vaccine on subsequent visits.

Volunteers will be prescreened to see if they qualify for the study. They can sign up through this link or through the website of the newly formed Center for Drug Safety and Immunology at VUMC, which Phillips directs, at: https://medsites.vumc.org/centerfordrugsafetyandimmunology/cdsi-studies.