Corona Virus Infection, COVID-19
Conditions
Keywords
mRNA vaccine, Adverse reactions, Vaccine re-challenge, Allergic reactions, Long COVID infection
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.
Interventions
BIOLOGICALPfizer-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.
BIOLOGICALModerna 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.
Sponsors
University of Michigan
The Wallace Foundation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | up to approximately 7 days after the vaccine is given | 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 |
| 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 (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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Non-allergic Clinical Adverse Reactions | up to approximately 7 days after the vaccine is given | Results reflect the number of participants who experienced a non-allergic clinical adverse reaction (AR). A non-allergic clinical AR was determined by non-allergic symptomatology and time frame from when the participant received a vaccine. Nonallergic ARs were symptoms that were inconsistent with an IgE-mechanism or had an onset greater than 1 hour following vaccination. 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJames Baker, MD
University of Michigan
Participant flow
Pre-assignment details
137 participants were consented. 18 participants withdrew prior to vaccination, 5 participants screen-failed, 1 participant was withdrawn by the investigator, and 10 participants were lost to follow-up. Participants chose which of the two vaccines (Pfizer-BioNTech or Moderna) they wanted to receive for the trial.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 15.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Long COVID diagnosis No diagnosis | 81 Participants |
| Long COVID diagnosis Physician diagnosis | 15 Participants |
| Long COVID diagnosis Self-diagnosis | 5 Participants |
| Previous COVID-19 vaccine status At least 1 booster dose | 83 Participants |
| Previous COVID-19 vaccine status Single dose | 5 Participants |
| Previous COVID-19 vaccine status Two doses | 11 Participants |
| Race/Ethnicity, Customized African American | 4 Participants |
| Race/Ethnicity, Customized Asian | 15 Participants |
| Race/Ethnicity, Customized More Than One Race | 1 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized Unknown | 3 Participants |
| Race/Ethnicity, Customized White | 72 Participants |
| Region of Enrollment United States | 6 Participants |
| Sex/Gender, Customized Female | 69 Participants |
| Sex/Gender, Customized Male | 31 Participants |
| Sex/Gender, Customized Undisclosed | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 6 |
| other Total, other adverse events | 72 / 97 | 3 / 6 |
| serious Total, serious adverse events | 0 / 97 | 0 / 6 |
Outcome results
None listed