COVID-19, Kidney Transplant
Conditions
Keywords
Kidney transplant, COVID-19, Vaccine
Brief summary
An open label, non-randomized pilot study in kidney transplant recipients who received a completed primary series and bivalent booster of mRNA based COVID-19 vaccine and have ≤2500 U/mL SARS-CoV-2 S antibody concentration using the Roche Elecsys(R) anti-RBD assay. Up to 80 participants will be enrolled in this study. Eligible participants will receive a dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine candidate.. The primary objective is to determine whether a booster dose of the Sanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine will elicit an increased SARS-CoV-2 antibody response in participants who have failed to maintain an antibody titer \>2500 U/mL (using the Roche Elecsys(R) anti-RBD assay) to 2 or more doses of mRNA based COVID-19 vaccine
Interventions
BIOLOGICALSanofi-GSK monovalent (B.1.351) CoV2 preS dTM-AS03 COVID-19 vaccine
0.5 mL per dose of the Sanofi-GSK COVID-19 Vaccine will be administered intramuscularly in the deltoid muscle of the upper arm
Sponsors
PPD Development, LP
Johns Hopkins University
Sanofi Pasteur, a Sanofi Company
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to understand and provide informed consent 2. Individual ≥ 18 years of age. 3. Recipient of kidney transplant ≥12 months prior to enrollment, without treated allograft rejection in the 6 months preceding enrollment 4. Maintenance immunosuppressive regimen consisting of CNI and mycophenolate mofetil or mycophenolate, with or without ≤ 5mg/day prednisone or equivalent 5. Received completed primary series (3 doses) of mRNA vaccine (either the Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) as specified in the respective package inserts 6. Receipt a COVID-19 bivalent mRNA booster (Moderna or Pfizer-BioNTech) \>30 days prior to enrollment. 7. Serum antibody titer up to 2500 U/mL at ≥ 30 days from the last dose of mRNA COVID-19 vaccine and * 30 days following receipt of a monoclonal antibody product or convalescent plasma for COVID-19, measured using the Roche Elecsys(R) anti-SARS-CoV-2 S assay 8. Platelet count greater than 30,000/cu mm must be confirmed in participants with a known history of bleeding disorder or thrombocytopenia (platelet count \<50,000/cu mm) 9. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: 1. Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile OR 2. Is of childbearing potential and agrees to use an effective contraceptive method or abstinence for 12 weeks post vaccine and while taking mycophenolate mofetil/mycophenolic acid
Exclusion criteria
1. Recipient of any number of doses of any COVID vaccine product other than the Moderna COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine 2. Recipient of any organ other than a kidney 3. Known current or prior Donor Specific Antibody (DSA) 4. Any change in transplant immunosuppression regimen (drug or dose) in response to suspected or proven rejection within the last 6 months 5. Known diagnosis of COVID-19 since last antibody test 6. Receipt of a monoclonal antibody product or convalescent plasma within the last 30 days 7. Known history of hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to a vaccine containing any of the same substances. (components listed in Section 6, and the CoV2 and AS03 Investigator's Brochure) 8. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating intramuscular (IM) vaccination based on Investigator's judgment 9. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided 10. Receipt of any vaccine in the 30 days preceding the study vaccine or planned vaccines in the 30 days following the study vaccine 11. Estimated Glomerular Filtration Rate \<30mL/min/1.73m\^2 12. Receipt of any cellular depleting agent (e.g. Antithymocyte globulin (ATG), Rituximab, Alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment 13. Receiving systemic immunomodulatory medication(s) for any condition other than transplant 14. Any uncontrolled active infection 15. Infection with human immunodeficiency virus (HIV) 16. Maintenance immunosuppressive regimen that includes anything other than a CNI, mycophenolate/mycophenolate mofetil, and ≤ 5mg/day prednisone or equivalent 17. Recent (within one year) or ongoing treatment for malignancy, except for definitive surgical treatment of localized skin cancers 18. Any unstable acute or chronic illness, treatments, or findings which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the c candidate's ability to comply with study requirements or may impact the quality or interpretation of the data obtained from the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL | At 30 days following a dose of vaccine | The antibody is measured by using the Roche Elecsys(R) anti-RBD assay |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | Within 30 days or within 60 days of the study dose of vaccine | — |
| Graft Loss | Within 30 days or within 60 days of the study dose of vaccine | — |
| Need for Dialysis | Within 30 days or within 60 days of the study dose of vaccine | — |
| Acute Rejection | Within 30 days or within 60 days of the study dose of vaccine | — |
| Local Vaccine Reactogenicity | Collected for 7 days following the study dose of vaccine) | — |
| Systemic Vaccine Reactogenicity | Collected for 7 days following the study dose of vaccine) | — |
| Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases | 1 year following the study dose of vaccine | The categories of AESI that required special reporting in this protocol were: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; Potential immune-mediated diseases (pIMDs) |
| Composite That Includes Death, Graft Loss, Need for Dialysis, and Acute Rejection | Within 30 days following the study dose of vaccine | — |
| Treated Antibody-mediated Allograft Rejection (Clinical or Biopsy-proven) | Within 60 days following the study dose of vaccine | — |
| Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody | Within 90 days of the vaccine and up to 12-months post vaccine | — |
| Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody | From study entry to 90 days post vaccine and up to 12-months post vaccine | — |
| Anti-RBD Antibody Concentration | At 30 days after the study dose of vaccine | The antibody is measured by using the Roche Elecsys(R) anti-RBD assay |
| Fold Rise (FR) in Anti-RBD Antibody Concentration | From baseline to 30 days after the study dose of vaccine | The Fold Rise is the dimensionless ratio between each participant's day 30 antibody titer (in U/ml) and the participant's baseline antibody titer (in U/ml) antibody is the antibody titers are measured by using the Roche Elecsys(R) anti-RBD assay. |
| Monogram Pseudovirus Antibody Titers | At 14 and 30 days after the study vaccine dose | For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability). tests unable to be performed |
| Median Range of Fold Rise (FR) in Monogram Pseudovirus Antibody Titers | From baseline to 14 and 30 days after the study vaccine dose | For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability) |
| Treated Acute Cell-mediated Allograft Rejection (Clinical or Biopsy-proven) | Within 60 days following the study dose of vaccine | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SARS CoV-2 Anti-RBD Persistently Low Kidney transplant recipients who have failed to maintain an antibody titer \>2500 U/ml (using the Roche Elecsys® anti-RBD assay) to a completed primary series and bivalent booster of mRNA based COVID-19 vaccine | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | SARS CoV-2 Anti-RBD Persistently Low |
|---|---|
| Age, Continuous | 71 years |
| Baseline SARS-CoV-2 Antibody Level | 223.5 U/mL |
| Days Between Last Vaccination and Antibody Screening | 222.5 days |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Number of Prior COVID-19 Vaccines Received Five | 11 Participants |
| Number of Prior COVID-19 Vaccines Received Four | 1 Participants |
| Number of Prior COVID-19 Vaccines Received Six | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 9 Participants |
| Years Since Transplant | 5.1 years |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 13 / 15 |
| serious Total, serious adverse events | 1 / 15 |
Outcome results
Primary
The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
Time frame: At 30 days following a dose of vaccine
Population: 1 participant received study vaccine but was excluded from primary immunogenicity population; baseline SARS-CoV-2 was initially misreported as eligible (≤ 2500 U/ml). This patient is included in the demographics/baseline description population and in non-immunogenicity clinical or safety outcomes (e.g. death, graft loss, need for dialysis, acute rejection).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | The Proportion of Participants Who Reach a SARS-CoV-2 S Antibody Level >5000 U/mL | 0 Participants |
Secondary
Acute Rejection
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Population: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Acute Rejection | Within 30 days | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Acute Rejection | Within 60 days | 0 Participants |
Secondary
Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases
The categories of AESI that required special reporting in this protocol were: Anaphylactic reactions; Generalized convulsion; Thrombocytopenia; Thrombosis with thrombocytopenia syndrome; Myocarditis; Pericarditis; Potential immune-mediated diseases (pIMDs)
Time frame: 1 year following the study dose of vaccine
Population: Safety Population (includes all subjects, including all follow-up for the 1 participant who decided to terminate early, and the 1 participant whose baseline antibody titer was misreported, and thus enrolled despite having an ineligible baseline antibody titer \> 2500 U/ml).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases | Experienced AESI | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Adverse Events of Special Interest (AESIs), Including Potential Immune Mediated Diseases | Did not experience AESI | 15 Participants |
Secondary
Anti-RBD Antibody Concentration
The antibody is measured by using the Roche Elecsys(R) anti-RBD assay
Time frame: At 30 days after the study dose of vaccine
Population: Immunogenicity population (Participant receiving study vaccine, with baseline SARS-CoV-2 S anti-RBD assay ≤ 2500 U/ml). 1 participant received study vaccine but was excluded from immunogenicity population; baseline SARS-CoV-2 was initially misreported as eligible.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Anti-RBD Antibody Concentration | 565 U/ml |
Secondary
Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody
Time frame: From study entry to 90 days post vaccine and up to 12-months post vaccine
Population: Safety population (Participant receiving study vaccine). 3 participants terminated the study prior to 1 year (1 after day 30, 2 after day 90). One participant decided to terminate the study after day 30, prior to 90 day or 1 year assessments; this participant had not experienced clinical or biopsy-proven antibody-mediated rejection at any time prior to termination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody | to 90 days post vaccine | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Change in Pre-existing Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody | to 1 year post vaccine | 0 Participants |
Secondary
Composite That Includes Death, Graft Loss, Need for Dialysis, and Acute Rejection
Time frame: Within 30 days following the study dose of vaccine
Population: Safety Population: Participant receiving study vaccine
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Composite That Includes Death, Graft Loss, Need for Dialysis, and Acute Rejection | 0 Participants |
Secondary
Death
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Population: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Death | Death within 30 days of vaccine | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Death | Death within 60 days of vaccine | 0 Participants |
Secondary
Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody
Time frame: Within 90 days of the vaccine and up to 12-months post vaccine
Population: Safety population (Participant receiving study vaccine). 3 participants terminated the study prior to 1 year (1 after day 30, 2 after day 90). One participant decided to terminate the study after day 30, prior to 90 day or 1 year assessments; this participant had not experienced clinical or biopsy-proven anitbody-mediated rejection at any time prior to termination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody | Development within 90 days of vaccine | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Development of de Novo Donor-specific Anti-human Leukocyte Antigens (HLA) Antibody | Development within 1 year of vaccine | 0 Participants |
Secondary
Fold Rise (FR) in Anti-RBD Antibody Concentration
The Fold Rise is the dimensionless ratio between each participant's day 30 antibody titer (in U/ml) and the participant's baseline antibody titer (in U/ml) antibody is the antibody titers are measured by using the Roche Elecsys(R) anti-RBD assay.
Time frame: From baseline to 30 days after the study dose of vaccine
Population: 1 participant received study vaccine but was excluded from immunogenicity population; baseline SARS-CoV-2 was initially misreported as eligible (≤ 2500 U/ml).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Fold Rise (FR) in Anti-RBD Antibody Concentration | 1.8 ratio |
Secondary
Graft Loss
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Population: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Graft Loss | Graft loss within 30 days of vaccine | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Graft Loss | Graft loss within 60 days of vaccine | 0 Participants |
Secondary
Local Vaccine Reactogenicity
Time frame: Collected for 7 days following the study dose of vaccine)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Injection Site Pain | Grade 1 (Mild) | 11 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Injection Site Pain | Grade 2 (Moderate) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Injection Site Pain | Grade 0 (None) | 3 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Redness | Grade 0 (None) | 14 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Redness | Grade 1 (Mild) | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Redness | Grade 2 (Moderate) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Swelling | Grade 0 (None) | 14 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Swelling | Grade 1 (Mild) | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Local Vaccine Reactogenicity | Swelling | Grade 2 (Moderate) | 1 Participants |
Secondary
Median Range of Fold Rise (FR) in Monogram Pseudovirus Antibody Titers
For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability)
Time frame: From baseline to 14 and 30 days after the study vaccine dose
Population: Data were not collected because tests were unable to be performed. Study funding was unexpectedly terminated prior to assessment of the samples. The assessment of these samples is not expected to be performed in the future.
Secondary
Monogram Pseudovirus Antibody Titers
For selected variants of concern (prototype (Wuhan), beta, and omicron BA.1; additional alternative strains to be determined based on assay availability). tests unable to be performed
Time frame: At 14 and 30 days after the study vaccine dose
Population: Data were not collected because tests were unable to be performed. Study funding was unexpectedly terminated prior to assessment of the samples. The assessment of these samples is not expected to be performed in the future.
Secondary
Need for Dialysis
Time frame: Within 30 days or within 60 days of the study dose of vaccine
Population: Safety population (Participant receiving study vaccine) 1 participant terminated the study after day 30. This patient who terminated prior to evaluation at 60 days had not had the 'event' at the time of termination and was censored.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Need for Dialysis | Need for dialysis within 30 days of vaccine | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Need for Dialysis | Need for dialysis within 60 days of vaccine | 0 Participants |
Secondary
Systemic Vaccine Reactogenicity
Time frame: Collected for 7 days following the study dose of vaccine)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Fever | Grade 0 (None) | 15 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Fever | Grade 1 (Mild) | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Fever | Grade 2 (Moderate) | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Headache | Grade 0 (None) | 14 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Headache | Grade 1 (Mild) | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Headache | Grade 2 (Moderate) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Tired | Grade 0 (None) | 10 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Tired | Grade 1 (Mild) | 4 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Tired | Grade 2 (Moderate) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Muscle Pain | Grade 0 (None) | 14 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Muscle Pain | Grade 1 (Mild) | 0 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Muscle Pain | Grade 2 (Moderate) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Joint Pain | Grade 0 (None) | 13 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Joint Pain | Grade 1 (Mild) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Joint Pain | Grade 2 (Moderate) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Chills | Grade 0 (None) | 13 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Chills | Grade 1 (Mild) | 1 Participants |
| SARS CoV-2 Anti-RBD Persistently Low | Systemic Vaccine Reactogenicity | Chills | Grade 2 (Moderate) | 1 Participants |
Secondary
Treated Acute Cell-mediated Allograft Rejection (Clinical or Biopsy-proven)
Time frame: Within 60 days following the study dose of vaccine
Population: Safety Population. 1 participant terminated the study after day 30, prior to 60 day follow-up. One participant decided to terminate the study after day 30, prior to 90 days assessment; this participant had not experienced clinical or biopsy-proven rejection at any time prior to termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Treated Acute Cell-mediated Allograft Rejection (Clinical or Biopsy-proven) | 0 Participants |
Secondary
Treated Antibody-mediated Allograft Rejection (Clinical or Biopsy-proven)
Time frame: Within 60 days following the study dose of vaccine
Population: Safety population (Participant receiving study vaccine). 1 participant terminated the study after day 30, prior to 60-day follow-up. One participant decided to terminate the study after day 30, prior to 60 days assessment; this participant had not experienced clinical or biopsy-proven anitbody-mediated rejection at any time prior to termination.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SARS CoV-2 Anti-RBD Persistently Low | Treated Antibody-mediated Allograft Rejection (Clinical or Biopsy-proven) | 0 Participants |