Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
- Conditions
- COVID-19Corona Virus Infection
- Interventions
- Biological: Pfizer-BioNTech mRNA COVID-19 vaccine
- Registration Number
- NCT05212610
- Lead Sponsor
- University of Michigan
- Brief Summary
This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection ("long COVID").
Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits.
We hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated.
The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pfizer-BioNTech mRNA COVID-19 vaccine Pfizer-BioNTech mRNA COVID-19 vaccine Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related allergic reaction adverse events up to approximately 7 days after the vaccine is given The safety of administering an initial or additional dose will be determined by using the grading of systemic allergic reactions will be based on a scale of 1-5 according to criteria set forth in the Consortium of Food Allergy Research (CoFAR) grading scale (version 3.0) modified for adults as well as the Brighton Collaboration to grade the diagnostic certainty of anaphylaxis.
Percent of participants that have a reaction to an initial or additional dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine up to approximately 7 days after the vaccine is given
- Secondary Outcome Measures
Name Time Method Number of clinical adverse reaction types (non-allergic) up to approximately 7 days after the vaccine is given The study will grade the severity of non-allergic adverse events experienced by the study participants according to the criteria set forth in the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007); hereafter, referred to as the FDA Toxicity Grading Scale. Adverse events will be graded on a scale from 1 to 5 according to the following standards in the FDA Toxicity Grading Scale.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States