Covid19
Conditions
Keywords
transplant patients
Brief summary
The purpose of this study is to investigate the efficient vaccine type as a booster dose for Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.
Interventions
BIOLOGICALBNT162b2 vaccine
Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
BIOLOGICALJNJ-78436735 Vaccine
Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
Sponsors
Giselle Guerra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years of age and older * Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas) transplant patient from living or deceased donors. * Patients with active graft with at least one immunosuppressive medication * Completed two doses of BNT162b2 vaccination at least 28 days ago
Exclusion criteria
* Patient with non-active graft * Any significant side effect with previous COVID-19 vaccination * Within 28 days of BNT162b2 vaccine completion * Already received more than and equal to three doses of COVID-19 vaccination * Previously received COVID-19 vaccine other than BNT162b2 vaccine * Previously received monoclonal Antibody treatment that are specifically directed against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab and/or any combination. * Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination) * History of Capillary Leak Syndrome * Adults unable to consent * Individuals who are not yet adults (younger than 18 year old) * Vulnerable patients (prisoners) * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | Up to 1 month (post booster vaccination) | Anti-spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) virus Immunoglobulin G (IgG) positivity rate will be assessed from serum blood samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With a Positive COVID-19 Test | Up to 1 month (post third dose) | As assessed by medical records and or patient's report |
| Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | Up to 1 month (post third dose) | World Health Organization (WHO) scale is scored between from 0 -10. 0: Uninfected; non-viral Ribonucleic Acid (RNA) detected 1. Asymptomatic; viral RNA detected 2. Symptomatic; Independent 3. Symptomatic; Assistance needed 4. Hospitalized; No oxygen therapy 5. Hospitalized; oxygen by mask or nasal prongs 6. Hospitalized; oxygen by Non-invasive Ventilation (NIV) or High flow 7. Intubation and Mechanical ventilation, partial pressure of oxygen (pO2) /fraction of inspired oxygen (FIO2) \>=150 or oxygen saturation (SpO2) /FIO2\>=200 8. Mechanical ventilation, (pO2/FIO2\<150 OR SpO2/FIO2\<200) or vasopressors (norepinephrine \>0.3 microg/kg/min) 9. Mechanical ventilation, pO2/FIO2\<150 and vasopressors (norepinephrine \>0.3 microg/kg/min), or Dialysis or extracorporeal membrane oxygenation (ECMO) 10. Dead |
| Number of Participants With Vaccine-related Adverse Events | Up to 7 days (post third dose) | Number of Participants with vaccine-related adverse events as collected by the study team. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BNT162b2 Vaccine Group Participants in this arm will receive one booster dose of the BNT162b2.
BNT162b2 vaccine: Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle | 30 |
| JNJ-78436735 Vaccine Group Participants in this arm will receive one booster dose of the JNJ-78436735
JNJ-78436735 Vaccine: Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle | 28 |
| Total | 58 |
Baseline characteristics
| Characteristic | JNJ-78436735 Vaccine Group | Total | BNT162b2 Vaccine Group |
|---|---|---|---|
| Age, Continuous | 54.5 years | 57.5 years | 59.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 22 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 36 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 22 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 35 Participants | 16 Participants |
| Sex: Female, Male Female | 11 Participants | 20 Participants | 9 Participants |
| Sex: Female, Male Male | 17 Participants | 38 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 13 / 30 | 20 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 |
Outcome results
Primary
Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Anti-spike protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2) virus Immunoglobulin G (IgG) positivity rate will be assessed from serum blood samples
Time frame: Up to 1 month (post booster vaccination)
Population: One patient on JNJ-78436735 vaccine group was not included in the analysis due to acquiring COVID-19 infection prior to the second blood draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BNT162b2 Vaccine Group | Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 83.3 percentage of participants |
| JNJ-78436735 Vaccine Group | Percentage of Participants Who Tested Positive for IgG Antibodies to the Anti-spike Protein of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | 85.2 percentage of participants |
Secondary
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
World Health Organization (WHO) scale is scored between from 0 -10. 0: Uninfected; non-viral Ribonucleic Acid (RNA) detected 1. Asymptomatic; viral RNA detected 2. Symptomatic; Independent 3. Symptomatic; Assistance needed 4. Hospitalized; No oxygen therapy 5. Hospitalized; oxygen by mask or nasal prongs 6. Hospitalized; oxygen by Non-invasive Ventilation (NIV) or High flow 7. Intubation and Mechanical ventilation, partial pressure of oxygen (pO2) /fraction of inspired oxygen (FIO2) \>=150 or oxygen saturation (SpO2) /FIO2\>=200 8. Mechanical ventilation, (pO2/FIO2\<150 OR SpO2/FIO2\<200) or vasopressors (norepinephrine \>0.3 microg/kg/min) 9. Mechanical ventilation, pO2/FIO2\<150 and vasopressors (norepinephrine \>0.3 microg/kg/min), or Dialysis or extracorporeal membrane oxygenation (ECMO) 10. Dead
Time frame: Up to 1 month (post third dose)
Population: One patient on JNJ-78436735 vaccine group was not included in the analysis due to acquiring COVID-19 infection prior to the second blood draw.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 2 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 6 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 1 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 7 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 3 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 8 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 0 | 30 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 9 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 4 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 10 | 0 Participants |
| BNT162b2 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 5 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 10 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 0 | 27 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 1 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 2 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 3 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 5 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 6 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 7 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 8 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 9 | 0 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale | WHO score of 4 | 0 Participants |
Secondary
Number of Participants With Vaccine-related Adverse Events
Number of Participants with vaccine-related adverse events as collected by the study team.
Time frame: Up to 7 days (post third dose)
Population: One patient on JNJ-78436735 vaccine group was not included in the analysis due to acquiring COVID-19 infection prior to the second blood draw.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BNT162b2 Vaccine Group | Number of Participants With Vaccine-related Adverse Events | Local Reaction | 9 Participants |
| BNT162b2 Vaccine Group | Number of Participants With Vaccine-related Adverse Events | Systemic reaction | 7 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With Vaccine-related Adverse Events | Local Reaction | 6 Participants |
| JNJ-78436735 Vaccine Group | Number of Participants With Vaccine-related Adverse Events | Systemic reaction | 5 Participants |
Secondary
Proportion of Participants With a Positive COVID-19 Test
As assessed by medical records and or patient's report
Time frame: Up to 1 month (post third dose)
Population: One patient on JNJ-78436735 vaccine group was not included in the analysis due to acquiring Coronavirus-19 (COVID-19) infection prior to the second blood draw.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BNT162b2 Vaccine Group | Proportion of Participants With a Positive COVID-19 Test | 0 proportion of participants |
| JNJ-78436735 Vaccine Group | Proportion of Participants With a Positive COVID-19 Test | 0 proportion of participants |