Rho to Coordinate Study Sponsored by NIAID to Assess Systemic Allergic Reactions to Pfizer and Moderna COVID-19 Vaccines
July 12, 2021
Research Triangle Park, NC – July 12, 2021 – Rho, a full-service contract research organization (CRO) with a proven track record of drug development success, today announced it is coordinating a study called Systemic Allergic Reactions to SARS-CoV-2 Vaccination to assess the proportion of participants with a systemic allergic reaction to the Pfizer-BioNTech and Moderna COVID-19 vaccines in populations at high risk for allergic reaction compared to a general population. This research will be important for further understanding potential risk factors for an allergic reaction to these particular vaccines, as well as to future vaccines that similarly use an mRNA nanoparticle platform. The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
“The fact that we have three authorized vaccines for COVID-19 within a year is a tremendous scientific achievement,” said Dr. Laura Helms Reece, CEO, Rho. “Being able to better understand how individuals who already have severe allergies respond to these life-saving vaccines will support a safe national vaccination program. Everyone at Rho is honored to be a part of this critical study.”
This study will enroll adult participants from 18-69 years of age. Approximately 60% of participants will be in the High-Allergy/Mast Cell Disorder (HA/MCD) group, and 40% will be less atopic. The MCD group will be limited to approximately 200 to 300 participants. Approximately two-thirds of participants enrolled in each of the two groups will be female, because severe allergic reactions to vaccines in general—and to the Moderna and Pfizer-BioNTech COVID-19 vaccines in particular—have occurred mainly in women. There will be approximately 30 clinical trial sites across the U.S., and the study duration for each participant is around 14 weeks.
Since introduction of the Pfizer-BioNTech and Moderna COVID-19 vaccines in a wider population, there have been rare reports of severe allergic reactions due to vaccination with these products, mostly in people with a history of allergies. This study is designed to investigate whether the risk for a systemic allergic reaction induced by the two mRNA COVID-19 vaccines in a population of individuals with a history of severe allergic reactions (High-Allergy [HA]) or mast cell disorders (MCD) is higher than in the general population.
Rho is participating under an administrative supplement to its Division of Allergy, Immunology, and Transplantation Statistical and Clinical Coordinating Center (DAIT SACCC) award (5UM2AI117870-07). The study is led by James R. Baker, JR., MD, Ruth Dow Doan Professor, Director, Mary H. Weiser Food Allergy Center, and Michigan Nanotechnology Institute for Medicine and the Biological Sciences; Rebecca S. Gruchalla, MD, PHD Professor and Chief, Division of Allergy and Immunology Departments of Internal Medicine and Pediatrics
University of Texas Southwestern; and N. Franklin Adkinson, JR., MD, Professor of Medicine & Program Director Graduate Training Program in Clinical Investigation, Associate TP Director, Allergy-Immunology Johns Hopkins Asthma & Allergy Center. Lisa M Wheatley, MD, MPH is leading the research in DAIT at NIAID.
As the DAIT SACCC, Rho is working closely with investigators to plan and execute the study design. Additionally, the CRO is providing operational management and oversight for all aspects of the study, including logistical support for biospecimen collection; collaborating to plan, implement, and monitor study data collection; timely reporting of safety events; and study data analysis and reporting.
Click here to learn more about Rho’s work on the study, as well as their clinical and regulatory support of the development of COVID-related vaccines, diagnostics, and treatments.
Adults interested in participating in this trial should visit www.ClinicalTrials.gov and search under study identifier NCT04761822 for study locations and contacts. More information about the trial is available on the NIAID website.
Rho, a privately held contract research organization (CRO) located in NC’s Research Triangle Park, provides a full range of drug development services from program strategy through clinical trials and marketing applications. For more than 35 years, Rho has been a trusted partner to some of the industry’s most innovative pharmaceutical, biotechnology and medical device companies, as well as academic and government organizations. Rho’s cross-functional collaborative approach, therapeutic expertise, and commitment to strong site relationships changes what it means to work with a CRO – ultimately accelerating time to market, maximizing returns on investment, and ensuring a consistent program that runs smarter and more efficiently. Experience Rho by following us on Facebook, LinkedIn and Twitter.