Clinical trial NCT05212610: Assessing Safety of Coronavirus Infection (COVID-19) Messenger RNA (mRNA) Vaccine Administration in the Setting of a Previous Adverse Reaction
Official title: Assessing Safety of COVID-19 mRNA Vaccine Administration in the Setting of a Previous Adverse Reaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Corona Virus Infection
Keywords: mRNA vaccine
Adverse reactions
Vaccine re-challenge
Allergic reactions
Long COVID infection
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: The Wallace Foundation
First posted: 2022-01-28
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent of participants that have a reaction to an initial or additional dose of the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine
timeFrame: up to approximately 7 days after the vaccine is given
measure: Number of participants with treatment-related allergic reaction adverse events
timeFrame: up to approximately 7 days after the vaccine is given
Secondary outcomes:
measure: Number of clinical adverse reaction types (non-allergic)
timeFrame: up to approximately 7 days after the vaccine is given
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: James Baker, MD
role: PRINCIPAL_INVESTIGATOR
References: