VOLUNTEERS NEEDED COVID-19 VACCINE STUDY

UVA Tracking #
HSR210056
Principal Investigator
Michael Nelson
Contact
Deborah Murphy
Contact Email
Contact Phone
434.982.3510
Official Trial Title
SYSTEMIC ALLERGIC REACTIONS TO SARS-COV-2 VACCINATION (SARS VACCINATION)
Study Description

The Asthma, Allergy and Immunology Division is recruiting volunteers to receive one of the two mRNA vaccines - Pfizer BioNtech COVID-19 Vaccine or Moderna COVID-19 Vaccine. These are the same vaccines that have received emergency use authorization (EUA) by the FDA and are being used at public vaccination sites. Everyone in the study will receive an EUA approved vaccine.

You may be eligible for this study if: You have a history of Severe Allergies, OR you have been diagnosed with a Mast Cell Disorder, OR you have a history of No Severe Allergies.

Study involves visiting the UVA Northridge Asthma, Allergy and Immunology clinic 2-3 times for vaccine. Depending on which vaccine you receive and whether you get placebo first, your participation will end in as short as 4 weeks, or up to 9 weeks. Before each vaccine dose is given, you will have a nasal swab collected for COVID-19 testing. You will also be asked to provide blood and urine samples before and after you receive each vaccine dose. We will watch you for 90 minutes after each dose, to see if you have an allergic reaction. If you have a reaction, the study doctors are trained to recognize and treat your reaction. Even if you do not have allergies, you have to stay the whole 90 minutes. After each dose, you will also be asked to track your symptoms for 1 week. You can use a website to track your symptoms or the paper form we give you. Someone from the study team will also call you to see how you’re doing.

One out of every 3 participants will receive a placebo (salt water) injection before they receive the first vaccine dose. You will not get to choose if you receive the placebo dose, or which vaccine you get. If you receive placebo first, you will still receive two doses of vaccine, per FDA guidelines. You will need to visit the clinical site a total of three times, if you receive placebo first. All participants will receive a validated vaccination card at the end of their study involvement.

Study-related exams, tests and vaccine are provided free of charge.

Compensation

$50 per study visit (2-4 visits total)