Phase 4
N=103
Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
COVID-19 · Corona Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT05212610 ↗Enrolled (actual)
103
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Participants Who Had a Reaction to an Initial or Additional Dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA Vaccine, or Who Had Long COVID — 71; 2; 1; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pfizer-BioNTech mRNA COVID-19 vaccine (Biological); Moderna mRNA COVID-19 vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Had a Reaction to an Initial or Additional Dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA Vaccine, or Who Had Long COVID |
71; 2; 1; 1; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-related Allergic Reaction Adverse Events |
3; 1; 1; 0; 0; 0 | — |
| SECONDARY Number of Non-allergic Clinical Adverse Reactions |
68; 1; 0; 1; 0; 0 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05212610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.