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

NCT ID: NCT05212610

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-21
• Study Completion Date: 2025-03-07

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pfizer-BioNTech mRNA COVID-19 vaccine

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

Group Type: EXPERIMENTAL

Pfizer-BioNTech mRNA COVID-19 vaccine

Intervention Type: 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.

Interventions

Pfizer-BioNTech mRNA COVID-19 vaccine

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

Comirnaty

Eligibility Criteria

Inclusion Criteria

1. Age over 18.

2. Participant must be able to understand and provide informed consent

3. 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.

4. 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.

5. Females of childbearing potential must have a negative pregnancy test prior to vaccination.

Exclusion Criteria

1. Under age 18

2. Inability or unwillingness of a participant to give written informed consent

3. Evidence of COVID-19 infection within 21 days of vaccination visit

4. History of antibody agent or convalescent plasma for treatment or prevention of COVID-19 within 90 days

5. 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.

6. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Wallace Foundation

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

James Baker Jr MD

Professor of Internal Medicine in Allergy/Clinical Immunology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Baker, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00206480

Identifier Type: -

Identifier Source: org_study_id