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

NCT05212610 | Completed Phase 4 Results FDA Drug

• 1 other identifier: HUM00206480
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Corona Virus Infection

Keywords

mRNA vaccine; Adverse reactions; Vaccine re-challenge; Allergic reactions; Long COVID infection

Outcome Measures

Primary Outcomes (2)

• 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

  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

  up to approximately 7 days after the vaccine is given

• Number of Participants With Treatment-related Allergic Reaction Adverse Events

  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.

  up to approximately 7 days after the vaccine is given

Secondary Outcomes (1)

• Number of Non-allergic Clinical Adverse Reactions

  up to approximately 7 days after the vaccine is given

Study Arms (2)

Pfizer-BioNTech mRNA COVID-19 vaccine

EXPERIMENTAL

Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine

Biological: Pfizer-BioNTech mRNA COVID-19 vaccine

Moderna mRNA COVID-19 vaccine

EXPERIMENTAL

Subject will receive an initial or additional dose of the Moderna mRNA COVID-19 vaccine

Biological: Moderna mRNA COVID-19 vaccine

Interventions

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.

Also known as: Comirnaty

Pfizer-BioNTech mRNA COVID-19 vaccine

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.

Moderna mRNA COVID-19 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• The Wallace Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Hypersensitivity

Interventions

BNT162 Vaccine; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: James Baker
• Organization: University of Michigan

jbakerjr@med.umich.edu

734-647-2777

Study Officials

• James Baker, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine in Allergy/Clinical Immunology

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 28, 2022
• Study Start: March 21, 2022
• Primary Completion: March 7, 2025
• Study Completion: March 7, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)