Cleveland Clinic will serve as the only clinical site in Ohio to participate in a national multi-center clinical trial to study severe allergic reaction to mRNA COVD-19 vaccines, according to a news release.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), is leading the trial to study the incidents of such anaphylactic reactions and whether certain risk factors increase the likelihood of experiencing the potentially life-threatening allergic reactions. Current research suggest anaphylaxis or severe allergic reaction to the mRNA vaccines (those manufactured by Pfizer or Moderna) occurs in about 2.5 to 5.5 people per 1 million doses, the release stated.
"We recognize that some people may be hesitant about getting vaccinated," said Dr. David Lang, chairman of the Department of Allergy & Immunology in the Cleveland Clinic Respiratory Institute, and a principal investigator of the trial, in a provided statement. "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."
Co-investigators include Dr. Steven Gordon, chairman of the Department of Infectious Disease, and allergists Dr. Mark Aronica, Dr. James Fernandez and Dr. Lily Pien.
The Clinic will recruit up to 113 patient volunteers. Overall, the study will enroll 3,400 adults across 35 academic allergy-research institutions nationwide, according to the release, which notes that 40% of study participants will have no history of allergies, while the rest will have a history of severe allergies or a diagnosis of a mast cell disorder (a condition where certain immune cells, called mast cells, build up under the skin and/or in the bones, intestines and other organs and can increase the risk of anaphylaxis).
Participants will be observed for at least 90 minutes after each injection — three times longer than current CDC guidance — in case any type of reaction occurs, and emergency medications, oxygen and medical equipment will be on hand, the release stated.
The national phase 2, randomized, placebo-controlled study aims to provide evidence-based data to help determine whether people with severe allergies, or a mast cell disorder, are at a greater risk of severe allergic reactions to the mRNA COVID-19 vaccines, according to the release.
Prospective study participants are those between the ages of 18 and 69 who have not already received a COVID-19 vaccine. Individuals in high-risk populations for illness from COVID-19 or severe allergic reactions to vaccines — such as people of African descent, Blacks, Hispanics and women — are especially encouraged to sign up, according to the release.
"Severe allergic reactions to the COVID-19 vaccines are very rare," Lang said. "The benefits of vaccination far outweigh the potential risk."