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Completed

NCT Number: NCT05212610

Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction

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.

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Key information

Conditions

COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Infections Hypersensitivity Immune System Diseases Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pfizer-BioNTech mRNA COVID-19 vaccine

Biological

Participants will receive an initial or additional dose of a highly protective COVID-19 mRNA vaccine for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in an environment where the investigators and staff are experienced in the care of patients with allergic reactions.

Other names: Comirnaty

Moderna mRNA COVID-19 vaccine

Biological

Participants will receive an initial or additional dose of a highly protective COVID-19 mRNA vaccine for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in an environment where the investigators and staff are experienced in the care of patients with allergic reactions.

Primary outcomes

  1. 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

    Time frame: up to approximately 7 days after the vaccine is given

    Results reflect the number of participants who had previously received the Pfizer-BioNTech, the Moderna mRNA COVID-19 vaccine, or both, and who had experienced an adverse reaction (AR). An AR would be any symptom reported or objective finding during the 30-minute observation, or any symptom reported at the 7 day follow up. ARs were graded using the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, which utilized the following grades:

    Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death

  2. Number of Participants With Treatment-related Allergic Reaction Adverse Events

    Time frame: 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 (mild reaction) to 5 (severe reaction, including death) 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. Results reflect the number of participants who received an initial dose or were revaccinated during the trial, and experienced related acute allergic reaction adverse event, and what the CoFAR severity for the events was. Events were deemed to be allergic if symptoms were consistent with an IgE-reaction and symptom onset began within 1 hour of vaccination.

Secondary outcomes

  1. Number of Non-allergic Clinical Adverse Reactions

    Time frame: up to approximately 7 days after the vaccine is given

    Results reflect the number of participants who experienced a non-allergic clinical adverse reaction (AR). A non-allergic clinical AR was determined by non-allergic symptomatology and time frame from when the participant received a vaccine. Nonallergic ARs were symptoms that were inconsistent with an IgE-mechanism or had an onset greater than 1 hour following vaccination. ARs were graded using the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, which utilized the following grades: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life-threatening Grade 5 = Death

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • The Wallace Foundation

Registry information

Official study title

Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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