Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
Study Details
Study Description
Brief Summary
This trial is being completed to understand whether people with a history of an adverse reaction to the first or second dose of either the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine can safely tolerate an additional dose or if individuals with a personal history of allergic reaction who declined COVID-19 vaccination administration can safely tolerate an initial dose.
Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 vaccine or the Moderna COVID-19 vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits.
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pfizer-BioNTech mRNA COVID-19 vaccine or Moderna mRNA COVID-19 vaccine Subject will receive an initial or additional dose of either the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine or the Moderna (Spikevax) mRNA COVID-19 vaccine |
Biological: 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.
Other Names:
Biological: Moderna 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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent of participants that have a reaction to an initial or additional dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine [up to approximately 7 days after the vaccine is given]
- Number of participants with treatment-related allergic reaction adverse events [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 1-5 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.
Secondary Outcome Measures
- Number of clinical adverse reaction types (non-allergic) [up to approximately 7 days after the vaccine is given]
The study will grade the severity of non-allergic adverse events experienced by the study participants according to the criteria set forth in the FDA Guidance for Industry Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (September 2007); hereafter, referred to as the FDA Toxicity Grading Scale. Adverse events will be graded on a scale from 1 to 5 according to the following standards in the FDA Toxicity Grading Scale.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must be able to understand and provide informed consent
-
No evidence of infectious illness (defined as fever >38 degrees celsius, vomiting, diarrhea, new cough, new shortness of breath, new congestion, new runny nose, new headache or sore throat) within 14 days of vaccine administration.
-
Participant must have a history of adverse reaction to either the Pfizer-BioNTech mRNA COVID vaccination or the Moderna mRNA COVID vaccination or have a personal history of allergic reaction and COVID vaccination avoidance.
-
Females of childbearing potential must have a negative pregnancy test prior to vaccination.
Exclusion Criteria:
-
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 an mRNA COVID-19 vaccination
-
History of underlying immune disorder.
-
Pregnancy
-
Immunocompromised
-
Participants with primary or acquired immunodeficiency
-
Participants on anti-rejection therapy following solid organ transplant or bone marrow transplant
-
Participants on biologic therapeutic agents
-
Participants with malignancy and ongoing or recent chemotherapy
-
Participants receiving systemic immunosuppressive therapy, including corticosteroids equivalent to 20 mg/day of prednisone for 2 weeks
-
Participants with chronic kidney disease stage 3 or higher
-
Participants with history of significant pulmonary compromise
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- The Wallace Foundation
Investigators
- Principal Investigator: James Baker, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00206480