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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19, Corona Virus Infection

Intervention / Treatment
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* Biological: Pfizer-BioNTech mRNA COVID-19 vaccine
* Biological: Moderna mRNA COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pfizer-BioNTech mRNA COVID-19 vaccine or Moderna mRNA COVID-19 vaccine<br>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<br>* 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.<br>* Other names: Comirnaty;Biological: Moderna mRNA COVID-19 vaccine<br>* 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.<br>* Other names: Spikevax;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | up to approximately 7 days after the vaccine is given | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of clinical adverse reaction types (non-allergic) | 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. | up to approximately 7 days after the vaccine is given | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mRNA vaccine, Adverse reactions, Vaccine re-challenge, Allergic reactions, Long COVID infection