Now that COVID vaccines have been approved for children this research is being expanded to determine whether highly allergic children or children with mast cell disorders (a buildup of the white blood cells that release substances causing symptoms similar to an allergic reaction) are more likely to have an allergic reaction to the Pfizer-BioNTech and Moderna COVID-19 vaccines than other people. We would also like to understand why some people have allergic reactions to these vaccines.
What does the study involve?
Participation could be as short as 29 days or as long as 43 days.
If you join the study, you will complete 2 to 4 clinic visits and have 3 to 4 phone calls over a period of 29 to 43 days, depending on which vaccine you receive and whether you get the additional placebo dose.
You will receive either the Pfizer-BioNTech or Moderna COVID-19 vaccine. Each vaccine requires two doses. If you don’t have a reaction to the first vaccine dose, you will receive the second vaccine dose. Some subjects may also receive a dose of placebo (salt water). You will receive three shots total, if you receive a placebo shot.
Who can participate?
Individuals who are 5 to 17 years of age and either have a history of serious allergic reaction, have a mast cell disorder, or have no allergies at all.
Where is it taking place?
16 sites across the U.S.
Is compensation provided?
As part of the screening process, you will receive $25 for completing the pre-screening visit. You will receive $100 for each visit that your child completes where he/she receives a study injection. You will receive $15 for each scheduled study telephone visit that your child completes. If additional follow-up visits are required for your child, you will receive $50 for each of these visits.
Number of visits?
2 to 4
Steps to Participate
Please go to http://www.covidvaccine-allergy.org/ for more information and information about how to contact a site near you.
Visit ClinicalTrials.gov for details.