TraCS' CTRC is site for National COVID mRNA Vaccine study in North Carolina

UNC School of Medicine's David Peden, MD, is the UNC site principal investigator of the NIH-sponsored study, and Scott Commins, MD, PhD, is co-PI. Participants can now enroll at UNC-Chapel Hill, the only site in North Carolina.

CHAPEL HILL, NC – The University of North Carolina School of Medicine has been selected as one of 29 sites in the United States to participate in the “Systemic Allergy Reactions to SARS-CoV-2 Vaccination (COVID-19-004),” a clinical study sponsored by the National Institute of Allergy and Infectious Diseases to determine if some individuals are more likely to have serious adverse reactions to mRNA vaccines against COVID-19.

David Peden, MD, the Andrews Distinguished Professor of Pediatrics and Deputy Director of the Center for Environmental Medicine, Asthma, and Lung Biology, is the principal investigator of the UNC site.

“This study is designed with two principal aims: to estimate the proportion of systemic allergic reactions to the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine, and to determine whether the risk of adverse vaccine reactions is higher in a High-Allergy/Mast Cell Disorder (MCD) population compared to people without a history of allergic reactions to food, medicine, or the environment,” said Peden, senior associate dean for translational research at the UNC School of Medicine and member of the UNC Children’s Research Institute.

“High-allergy” refers to people who are prone to allergic reactions. Mast cell conditions are rare but cause a particular type of allergic reaction leading to symptoms such as flushing, hives, abdominal pain, bloating, low blood pressure, severe diarrhea, and difficulty breathing.

Allergic reactions have been reported to occur after vaccination with both the Pfizer-BioNTech COVID-19 vaccine and Moderna COVID-19 vaccine. Allergic reactions range from mild to severe and include life-threatening anaphylactic reactions, although no deaths have been attributed to either vaccine after hundreds of millions of doses given.

Approximately 2040 HA/MCD and 1360 non-atopic participants (with no history or allergies) will be enrolled across participating sites in the United States starting today. Approximately two-thirds of participants enrolled in each group will be female because the vast majority of cases of anaphylaxis to the COVID-19 vaccines have occurred in women. Enrollment of participants who qualify only on the basis of reactions to multiple unrelated drugs will be limited to approximately 300.

Participants in each population will be randomized into one of four groups: individuals who receive the Pfizer-BioNTech COVID-19 Vaccine, Moderna COVID-19 Vaccine, placebo + Pfizer-BioNTech COVID-19 vaccine, or placebo + Moderna COVID-19 vaccine.

Participants randomized into one of the placebo groups will receive placebo as a first dose and will receive two doses of their assigned active vaccine at subsequent visits.

During a follow-up call scheduled three days after the second injection, participants will be told whether they received placebo or active vaccine at their first and/or second visit.

Scott Commins, MD, PhD, professor of medicine and one of the world’s foremost experts in the mysterious alpha-gal meat allergy, is co-principal investigator at the UNC site. Other UNC investigators are Edwin Kim, MD, Onyi Iweala, MD, PhD, and Allison Burbank, MD, all part of the UNC Children’s Research Institute. Collaborators from the Environmental Protection Agency include Ann Chelminski, MD, and Andrew Ghio, MD.

At UNC-Chapel Hill, the research will take place at the NC TraCS Clinical and Translational Research Center (CTRC) in the Burnett-Womack Building and the EPA Building on Mason Farm Road.

Volunteers can learn more and sign up to volunteer at clinicaltrials.gov or call lead study coordinator Martha Almond at 919.966.0759.