| Primary | The -Fold Change in Antibody Titer (Using the Roche Elecsys® Anti-SARS-CoV-2 S Assay) From Before Receiving the Study Dose of Vaccine to 30 Days After the Study Dose of Vaccine. | Serum antibody titer will be measured using the Roche Elecsys®) severe acute respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay. Values > 1 represent increase from baseline; values < 1 represent decrease from baseline. | 1 ISR participant missed Day 0 antibody titer; 1 ISR participant was deemed ineligible for taking >5mg of prednisone; 1 Vaccine only participant terminated the study prior to Day 30 follow-up | Posted | | Median | Inter-Quartile Range | dimensionless ratio | | Day 30 After Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00013(5 to 58)
- OG00131(5 to 72)
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| Secondary | Frequency of Solicited Systemic Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | | Posted | | Number | | events | | Through Day 7 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Proportion of Participants With Local Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | Specific local reactions were collected by the participant: pain at the injection site, redness, and swelling. These local reactions after the vaccine dose were reported. There were no reported Grade 2 (moderate) or higher grade local solicited adverse reactions. | Posted | | Count of Participants | | Participants | | Through Day 7 post Vaccine dose | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. | | OG001 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. |
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| Secondary | Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | Specific Systemic Reactions were collected by the participant: fever, myalgia, arthralgia, fatigue, headache, nausea, vomiting, diarrhea, chills. These systemic reactions after the vaccine dose were reported. There were no reported Grade 2 (moderate) or higher grade systemic solicited adverse reactions. | Posted | | Count of Participants | | Participants | | Through Day 7 post Vaccine dose | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. | | OG001 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. |
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| Secondary | Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | Specific Solicited Potential Allergic Reactions were collected by the participant: skin allergic reactions (hives, swelling other than at the injection site, itching, redness other than at the injection site, rash), respiratory allergic reactions (wheezing, shortness of breath, coughing, tightness in the throat or chest, sneezing, nasal stuffiness or congestion), gastrointestinal allergic reactions, and dizziness or lightheadedness. | Posted | | Count of Participants | | Participants | | Through Day 7 post Vaccine dose | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Frequency of Any Serious Adverse Events (SAEs) During the 30 Days Following the Additional Dose of Vaccine | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | | Posted | | Number | | events | | Through Day 30 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection | Safety measure post receipt of the study's COVID-19 mRNA vaccine. | All events occurring during study participation from all participants receiving study intervention were included in this analysis, even if the participant terminated the study prior to the full 60 day period of surveillance. 1 vaccine only participant terminated the study after day 21, 2 additional vaccine only participants terminated the study after day 44. | Posted | | Count of Participants | | Participants | | Through Day 60 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Proportion of Participants Who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | All events occurring during study participation from all participants receiving study intervention were included in this analysis, even if the participant terminated the study prior to the full 90 day period of surveillance for donor-specific HLA antibodies. 1 vaccine only participant terminated the study after day 21; 2 vaccine only participants terminated the study after day 44, prior to 90 d follow-up. | Posted | | Count of Participants | | Participants | | Through Day 90 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Proportion of Participants With Graft Loss | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | All events occurring during study participation from all participants receiving study intervention were included in this analysis, even if the participant terminated the study prior to the full 60 day period of surveillance for graft loss. 1 vaccine only participant terminated the study after day 21; 2 vaccine only participants terminated the study after day 44. | Posted | | Count of Participants | | Participants | | Through Day 60 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Occurrence of Death Among Participants | Safety measure after receipt of the study's COVID-19 mRNA vaccine. | All events occurring during study participation from all participants receiving study intervention were included in this analysis, even if the participant terminated the study prior to the full 60 day period of surveillance for death. 1 vaccine only participant terminated the study after day 21; 2 vaccine only participants terminated the study after day 44. | Posted | | Count of Participants | | Participants | | Through Day 60 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR) | A nasal mid-turbinate swab for SARS-CoV-2 PCR testing will be collected prior to administration of the COVID-19, at specified timepoints after receipt of vaccination and, in any case of suspected COVID-19 infection. | Number analyzed represents those who submitted an analyzable sample at each specific study visit timepoint and does not include positive SARS-CoV-2 tests obtained at non-study visits. | Posted | | Count of Participants | | Participants | | Baseline (Day 0, Prior to Study Vaccination), Month 1, 3, 6, 9 and 12 | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Occurrence of Symptomatic COVID-19 | Efficacy measure after receipt of the study's COVID-19 mRNA vaccine. | All events occurring during study participation from all participants receiving study intervention were included in this analysis, even if the participant terminated the study prior to the full 365 day period of surveillance for symptomatic COVID-19. 1 vaccine only participant terminated the study after day 21; 2 vaccine only participants terminated the study after day 44. | Posted | | Count of Participants | | Participants | | Through Day 365 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Occurrence of COVID-19 Requiring Hospitalization | Efficacy measure after receipt of the study's COVID-19 mRNA vaccine. | All events occurring during study participation from all participants receiving study intervention were included in this analysis, even if the participant terminated the study prior to the full 365 day period of surveillance for COVID-19 requiring hospitalization. 1 vaccine only participant terminated the study after day 21; 2 vaccine only participants terminated the study after day 44. | Posted | | Count of Participants | | Participants | | Through Day 365 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Change From Baseline in Anti-SARS-CoV-2 Antibody Levels at Day 30 | Efficacy measure after receipt of the study's COVID-19 mRNA vaccine. | All participants with eligible analyzable samples were included in this analysis. 1 ISR participant missed Day 0 antibody titer and the change could not be analyzed; 1 ISR participant was deemed ineligible for taking >5mg of prednisone and was excluded from analysis; 1 Vaccine only participant terminated the study prior to Day 30 follow-up, and without a sample could not be included in analysis. | Posted | | Median | Inter-Quartile Range | U/mL | | Baseline (Day 0, Prior to Study Vaccination),Day 30 After Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Change From Baseline in SARS-CoV-2 Antibody Levels | Efficacy measure after receipt of the study's COVID-19 mRNA vaccine. | All participants with eligible analyzable samples were included in this analysis. 1 ISR participant missed Day 0 antibody titer and the change could not be analyzed; 1 ISR participant was deemed ineligible for taking >5mg of prednisone and was excluded from analysis; 1 Vaccine only participant terminated the study prior to Day 30 follow-up, and without a sample could not be included in analysis. | Posted | | Median | Inter-Quartile Range | U/mL | | From Baseline (Day 0, Prior to Study Vaccination) to Day 365 Post Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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| Secondary | Fold Change in SARS-CoV-2 Antibody Levels: Limited to Participants With Detectable Antibody Levels at Baseline (Day 0). (Values > 1 Represent an Increase From Baseline; Values < 1 Represent a Decrease From Baseline). | Efficacy measure after receipt of the study's COVID-19 mRNA vaccine. | All participants with eligible analyzable samples were included in this analysis. 1 ISR participant missed Day 0 antibody titer and the change could not be analyzed; 1 ISR participant was deemed ineligible for taking >5mg of prednisone and was excluded from analysis; 1 Vaccine only participant terminated the study prior to Day 30 follow-up, and without a sample could not be included in analysis. | Posted | | Median | Inter-Quartile Range | dimensionless ratio | | Baseline (Day 0, Prior to Receipt of COVID-19 Study Vaccination), Day 30 After Study Vaccination | | | | ID | Title | Description |
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| OG000 | Additional mRNA COVID-19 Vaccine Without ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 and will continue to take their standard of care transplant immunosuppressive medications without alterations in schedule and dosing. | | OG001 | Additional mRNA COVID-19 Vaccine With ISR | Participants will receive a study dose (1 dose) of the Pfizer-BioNTech COVID-19 Vaccine 2023-2024 or the Moderna COVID-19 Vaccine 2023-2024 with concurrent reduction of their standard of care transplant immunosuppression regimen. |
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