CLEVELAND — Cleveland Clinic is recruiting 113 study volunteers, who will be compensated, to participate in research into whether certain factors make them more prone to allergic reactions from COVID-19 vaccines.
Severe allergic reactions are very rare, but researchers need to know potential risk factors so people can get an alternative.
According to the Centers for Disease Control and Prevention, more than 237 million doses of the mRNA COVID-19 vaccines manufactured by Pfizer or Moderna have been administered in the United States. Current research suggests that anaphylaxis – or a severe allergic reaction – to these mRNA vaccines occurs in about 2.5 to 5.5 people per 1 million doses.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is leading a multi-center clinical trial to study the incidence of anaphylactic reactions to mRNA vaccines, and whether certain risk factors increase the likelihood of experiencing these potentially life-threatening allergic reactions.
Cleveland Clinic is the only clinical site in Ohio involved in the study and will recruit up to 113 patient volunteers. Overall, this study will enroll 3,400 adults across 35 academic allergy-research institutions nationwide. About 60% of study participants will have a history of severe allergies or a diagnosis of a mast cell disorder. The remaining 40% will have no history of allergies.
“We recognize that some people may be hesitant about getting vaccinated, participants in this study will receive either the Pfizer or the Moderna vaccine under the watchful eye of an allergist trained to recognize and treat anaphylaxis," said David Lang, M.D., chairman of the Department of Allergy & Immunology in the Cleveland Clinic Respiratory Institute, is a principal investigator of the trial.
Emergency medications, oxygen and medical equipment will be on hand to treat allergic reactions as needed. Participants will be observed for at least 90 minutes after each injection in case any type of reaction occurs—three times longer than current CDC guidance.
Prospective study participants will be between the ages of 18-69 years. People who have already received a COVID-19 vaccine (Pfizer, Moderna or Johnson & Johnson) are not eligible to participate.
Individuals in high-risk populations for illness from COVID-19 or severe allergic reactions to vaccines –such as people of African descent, African Americans, Hispanics and women – are especially encouraged to sign up.
After each injection, participants will be asked to monitor their symptoms for one week and will be contacted after each injection by the study team. Depending on whether participants receive the placebo, participation in the trial will last four to nine weeks.
For more information about participating in this study, call 216-444-8758 or email sarsvaccine@ccf.org.
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