Trial Outcomes & Findings for COVID Protection After Transplant-Immunosuppression Reduction (NCT NCT05077254)
NCT ID: NCT05077254
Last Updated: 2026-04-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day 30 After Study Vaccination
Results posted on
2026-04-23
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
COVID Protection After Transplant-Immunosuppression Reduction
Baseline characteristics by cohort
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
n=60 Participants
|
63 years
n=56 Participants
|
62.5 years
n=116 Participants
|
|
Sex/Gender, Customized
Female
|
6 Participants
n=60 Participants
|
10 Participants
n=56 Participants
|
16 Participants
n=116 Participants
|
|
Sex/Gender, Customized
Male
|
12 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
16 Participants
n=116 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=60 Participants
|
10 Participants
n=56 Participants
|
22 Participants
n=116 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
8 Participants
n=116 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
1 Participants
n=116 Participants
|
|
Race/Ethnicity, Customized
Other
|
16 Participants
n=60 Participants
|
14 Participants
n=56 Participants
|
30 Participants
n=116 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino ethnicity
|
2 Participants
n=60 Participants
|
0 Participants
n=56 Participants
|
2 Participants
n=116 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=60 Participants
|
14 participants
n=56 Participants
|
32 participants
n=116 Participants
|
|
Years since transplant
|
3.2 Years
n=60 Participants
|
4.1 Years
n=56 Participants
|
3.9 Years
n=116 Participants
|
|
Organ transplanted
Kidney
|
13 Participants
n=60 Participants
|
10 Participants
n=56 Participants
|
23 Participants
n=116 Participants
|
|
Organ transplanted
Liver
|
5 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
9 Participants
n=116 Participants
|
|
Baseline Immunosuppression
Tacrolimus, MMF or MPA, with/without corticosteroid
|
14 Participants
n=60 Participants
|
9 Participants
n=56 Participants
|
23 Participants
n=116 Participants
|
|
Baseline Immunosuppression
Tacrolimus with <= 5mg prednisone or equivalent
|
0 Participants
n=60 Participants
|
4 Participants
n=56 Participants
|
4 Participants
n=116 Participants
|
|
Baseline Immunosuppression
Tacrolimus only
|
4 Participants
n=60 Participants
|
1 Participants
n=56 Participants
|
5 Participants
n=116 Participants
|
PRIMARY outcome
Timeframe: Day 30 After Study VaccinationPopulation: 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
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.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=17 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=12 Participants
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.
|
|---|---|---|
|
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.
|
13 dimensionless ratio
Interval 5.0 to 58.0
|
31 dimensionless ratio
Interval 5.0 to 72.0
|
SECONDARY outcome
Timeframe: Through Day 7 Post Study VaccinationSafety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Frequency of Solicited Systemic Allergic Reaction Adverse Events (AEs) to the mRNA-Based COVID-19 Vaccine
|
0 events
|
0 events
|
SECONDARY outcome
Timeframe: Through Day 7 post Vaccine dosePopulation: 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.
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Proportion of Participants With Local Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Any Local Solicited Adverse Reaction
|
7 Participants
|
6 Participants
|
|
Proportion of Participants With Local Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Injection Site Pain - Grade 1 (Mild) 7/18 38.89% 6/14 42.14%
|
7 Participants
|
6 Participants
|
|
Proportion of Participants With Local Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Swelling - Grade 1 (Mild)
|
0 Participants
|
1 Participants
|
|
Proportion of Participants With Local Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Erythema/Redness - any Grade >= 1
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 7 post Vaccine dosePopulation: 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.
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Vomiting - Any grade >= 1
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Myalgia - Grade 1
|
0 Participants
|
1 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Arthralgia - Any grade >= 1
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Chills - Grade 1 (Mild)
|
1 Participants
|
0 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Diarrhea - Any grade >= 1
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Fatigue - Grade 1 (Mild)
|
3 Participants
|
3 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Headache - Grade 1 (Mild)
|
0 Participants
|
1 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Nausea - Grade 1 (Mild)
|
0 Participants
|
1 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Any Systemic Solicited Adverse Reaction
|
4 Participants
|
3 Participants
|
|
Proportion of Participants With Systemic Solicited Adverse Reactions Within 7 Days After Additional Vaccine Dose
Fever - Grade 1
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through Day 7 post Vaccine dosePopulation: 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.
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose
Any Respiratory Signs/Symptoms of Potential Allergic Reaction
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose
Any Gastrointestinal Signs/Symptoms of Potential Allergic Reaction
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose
Dizziness or Lightheadedness
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose
Any Skin Signs/Symptoms of Potential Allergic Reaction
|
0 Participants
|
0 Participants
|
|
Proportion of Participants With Solicited Potential Allergic Reactions Within 7 Days After Additional Vaccine Dose
Any Solicited Potential Allergic Reactions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 30 Post Study VaccinationSafety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Frequency of Any Serious Adverse Events (SAEs) During the 30 Days Following the Additional Dose of Vaccine
Had >= 1 Adverse Event
|
2 events
|
0 events
|
|
Frequency of Any Serious Adverse Events (SAEs) During the 30 Days Following the Additional Dose of Vaccine
No Serious Adverse Events
|
16 events
|
14 events
|
SECONDARY outcome
Timeframe: Through Day 60 Post Study VaccinationPopulation: 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.
Safety measure post receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Proportion of Participants Treated for Acute Cell-Mediated and/or Antibody-Mediated Allograft Rejection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 90 Post Study VaccinationPopulation: 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.
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Proportion of Participants Who Develop de Novo Donor-Specific Anti-Human Leukocyte Antigens (HLA) Antibody
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 60 Post Study VaccinationPopulation: 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.
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Proportion of Participants With Graft Loss
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through Day 60 Post Study VaccinationPopulation: 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.
Safety measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Occurrence of Death Among Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0, Prior to Study Vaccination), Month 1, 3, 6, 9 and 12Population: 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.
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.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)
Baseline
|
0 Participants
|
0 Participants
|
|
Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)
Month 1
|
0 Participants
|
2 Participants
|
|
Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)
Month 3
|
0 Participants
|
0 Participants
|
|
Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)
Month 6
|
1 Participants
|
1 Participants
|
|
Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)
Month 9
|
0 Participants
|
0 Participants
|
|
Frequency of Positive SARS-CoV-2 Test Results Using Real-Time Polymerase Chain Reaction (RT-PCR)
Month 12
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Through Day 365 Post Study VaccinationPopulation: 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.
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Occurrence of Symptomatic COVID-19
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Through Day 365 Post Study VaccinationPopulation: 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.
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 Participants
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.
|
|---|---|---|
|
Occurrence of COVID-19 Requiring Hospitalization
Participants requiring any COVID-19 related hospitalization
|
4 Participants
|
1 Participants
|
|
Occurrence of COVID-19 Requiring Hospitalization
Participants not requiring any COVID-19 related hospitalization
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0, Prior to Study Vaccination),Day 30 After Study VaccinationPopulation: 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.
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=17 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=12 Participants
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.
|
|---|---|---|
|
Change From Baseline in Anti-SARS-CoV-2 Antibody Levels at Day 30
|
104 U/mL
Interval 7.0 to 1111.0
|
294 U/mL
Interval 14.0 to 4757.0
|
SECONDARY outcome
Timeframe: From Baseline (Day 0, Prior to Study Vaccination) to Day 365 Post Study VaccinationPopulation: 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.
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=14 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=11 Participants
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.
|
|---|---|---|
|
Change From Baseline in SARS-CoV-2 Antibody Levels
|
685 U/mL
Interval 99.0 to 7376.0
|
1878 U/mL
Interval 172.0 to 3392.0
|
SECONDARY outcome
Timeframe: Baseline (Day 0, Prior to Receipt of COVID-19 Study Vaccination), Day 30 After Study VaccinationPopulation: 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.
Efficacy measure after receipt of the study's COVID-19 mRNA vaccine.
Outcome measures
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=17 Participants
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=12 Participants
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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|---|---|---|
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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).
|
13 dimensionless ratio
Interval 5.8 to 58.0
|
31 dimensionless ratio
Interval 5.0 to 72.0
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Adverse Events
Additional mRNA COVID-19 Vaccine Without ISR
Serious events: 5 serious events
Other events: 6 other events
Deaths: 1 deaths
Additional mRNA COVID-19 Vaccine With ISR
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 participants at risk
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
COVID-19 infection
|
16.7%
3/18 • Number of events 3 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Gastrointestinal disorders
Colitis
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
Other adverse events
| Measure |
Additional mRNA COVID-19 Vaccine Without ISR
n=18 participants at risk
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.
|
Additional mRNA COVID-19 Vaccine With ISR
n=14 participants at risk
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.
|
|---|---|---|
|
Investigations
Lymphocyte count decreased
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
7.1%
1/14 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Investigations
WBC count decreased
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
7.1%
1/14 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Investigations
ALT increased
|
0.00%
0/18 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
7.1%
1/14 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Investigations
Blood bicarbonate decreased
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Investigations
Blood creatinine increased
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
35.7%
5/14 • Number of events 6 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Investigations
CD4 lymphocytes decreased
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Infections and infestations
COVID-19 infection
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
14.3%
2/14 • Number of events 2 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/18 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
7.1%
1/14 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
7.1%
1/14 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.6%
1/18 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
0.00%
0/14 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/18 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
7.1%
1/14 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/18 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
7.1%
1/14 • Number of events 1 • Serious Adverse Events were collected through 6 months after vaccination. Non-serious AE were collected for 30 days after vaccination. (Also see note at end of table).
|
Additional Information
Director, Clinical Research Operations Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place