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| Name | Class |
|---|---|
| The Wallace Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pfizer-BioNTech mRNA COVID-19 vaccine | Experimental | Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine |
|
| Moderna mRNA COVID-19 vaccine | Experimental | Subject will receive an initial or additional dose of the Moderna mRNA COVID-19 vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pfizer-BioNTech mRNA COVID-19 vaccine | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 (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. | up to approximately 7 days after the vaccine is given |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Non-allergic Clinical Adverse Reactions | 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 |
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Inclusion Criteria
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 chronic kidney disease stage 3 or higher
Persons with history of significant pulmonary compromise
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| Name | Affiliation | Role |
|---|---|---|
| James Baker, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pfizer-BioNTech mRNA COVID-19 Vaccine | Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 1, 2024 |
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| Moderna mRNA COVID-19 vaccine | 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. |
|
| up to approximately 7 days after the vaccine is given |
| FG001 | Moderna mRNA COVID-19 Vaccine | Subject will receive an initial or additional dose of the Moderna mRNA COVID-19 vaccine 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. |
| COMPLETED | Completed meant participant was administered a vaccine and responded at the 7-day follow up. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pfizer-BioNTech mRNA COVID-19 Vaccine | Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine 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. |
| BG001 | Moderna mRNA COVID-19 Vaccine | Subject will receive an initial or additional dose of the Moderna mRNA COVID-19 vaccine 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Previous COVID-19 vaccine status | Count of Participants | Participants |
| ||||||||||||||||
| Long COVID diagnosis | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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 | Data was collected at the 7-day follow-up. 2 participants were lost to follow up, so no data was collected for them. | Posted | Count of Participants | Participants | up to approximately 7 days after the vaccine is given |
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| Primary | 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 (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. | Data was collected at the 7-day follow-up. 2 participants were lost to follow up, so no data was collected for them. | Posted | Count of Participants | Participants | up to approximately 7 days after the vaccine is given |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Non-allergic Clinical Adverse Reactions | 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 | Data was collected at the 7-day follow-up. 2 participants were lost to follow up, so no data was collected for them. | Posted | Count of Participants | Participants | up to approximately 7 days after the vaccine is given |
|
up to approximately 7 days after the vaccine is given
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pfizer-BioNTech mRNA COVID-19 Vaccine | Subject will receive an initial or additional dose of the Pfizer-BioNTech (Comirnaty) mRNA COVID-19 vaccine 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. | 0 | 97 | 0 | 97 | 72 | 97 |
| EG001 | Moderna mRNA COVID-19 Vaccine | Subject will receive an initial or additional dose of the Moderna mRNA COVID-19 vaccine 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. | 0 | 6 | 0 | 6 | 3 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Muscle Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Headache | General disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Lip swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Migraine | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Baker | University of Michigan | 734-647-2777 | jbakerjr@med.umich.edu |
| Mar 2, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
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| Male |
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| Undisclosed |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| African American |
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| White |
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| More Than One Race |
|
| Other |
|
| Unknown |
|
| Two doses |
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| At least 1 booster dose |
|
| Self-diagnosis |
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| No diagnosis |
|
| Grades 3-5 |
|
| Moderna mRNA COVID-19 Vaccine |
Subject will receive an initial or additional dose of the Moderna mRNA COVID-19 vaccine 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. |
|
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Subject will receive an initial or additional dose of the Moderna mRNA COVID-19 vaccine
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.
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