Status:
COMPLETED
Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
The Wallace Foundation
Conditions:
COVID-19
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 previou...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age over 18.
- Participant must be able to understand and provide informed consent
- No evidence of infectious illness (defined as fever \>38⁰C, vomiting, diarrhea, new cough, new shortness of breath, new congestion, new runny nose, new headache or sore throat) within 14 days of vaccine administration.
- Subjects must have a history of adverse reaction to either the Pfizer-BioNTech mRNA COVID vaccination or the Moderna mRNA COVID vaccination, a personal history of allergic reaction without prior mRNA COVID vaccination, or a history of adverse reaction to natural COVID infection.
- Females of childbearing potential must have a negative pregnancy test prior to vaccination.
- Exclusion Criteria
- Under age 18
- Inability or unwillingness of a participant to give written informed consent
- Evidence of COVID-19 infection within 21 days of vaccination visit
- History of antibody agent or convalescent plasma for treatment or prevention of COVID-19 within 90 days
- Individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech mRNA COVID-19 vaccination or the Moderna mRNA COVID-19 vaccination.
- History of underlying immune disorder.
- Pregnancy
- Immunocompromised
- Persons with primary or acquired immunodeficiency
- Persons on anti-rejection therapy following solid organ transplant or bone marrow transplant
- Persons on biologic therapeutic agents
- Persons with malignancy and ongoing or recent chemotherapy
- Persons receiving systemic immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day of prednisone for 2 weeks
- Persons with chronic kidney disease stage 3 or higher
- Persons with history of significant pulmonary compromise
Exclusion
Key Trial Info
Start Date :
March 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 7 2025
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT05212610
Start Date
March 21 2022
End Date
March 7 2025
Last Update
April 17 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109