COVID-19: SARS Vaccination (SARS)
This is a multicenter, randomized, initially blinded (masked), phase 2 trial to assess SARS-CoV-2 vaccination reactions in two populations:
- One population including individuals with a history of allergic reactions or Mast Cell Disorder (HA/MCD),and
- One allergy-free population.
Approximately 2040 High-Allergy/Mast Cell Disorder (HA/MCD) and 1360 participants without allergies will be enrolled across participating sites in the United States (3400 total participants). Approximately two-thirds of participants enrolled in each of the 2 groups will be female. This is because the vast majority of cases of anaphylaxis to the COVID-19 vaccines have occurred in women.
Study Duration: Randomized and vaccinated participants will complete study participation in approximately 29 days if vaccinated with the Pfizer-BioNTech COVID-19 Vaccine, 36 days if vaccinated with the Moderna COVID-19 Vaccine, and 50 or 64 days if administered placebo before receiving two doses of either the Pfizer-BioNTech COVID-19 Vaccine or the Moderna COVID-19 Vaccine, respectively.
Total study duration: Approximately 17 weeks.