Trial Outcomes & Findings for COVID-19 3rd Dose Vaccine in Transplant Patients (NCT NCT05047640)
NCT ID: NCT05047640
Last Updated: 2024-06-04
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
58 participants
Primary outcome timeframe
Up to 1 month (post booster vaccination)
Results posted on
2024-06-04
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 3rd Dose Vaccine in Transplant Patients
Baseline characteristics by cohort
| Measure |
BNT162b2 Vaccine Group
n=30 Participants
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
|
JNJ-78436735 Vaccine Group
n=28 Participants
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
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
n=39 Participants
|
54.5 years
n=41 Participants
|
57.5 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=39 Participants
|
17 Participants
n=41 Participants
|
38 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
35 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
BNT162b2 Vaccine Group
n=30 Participants
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
|
JNJ-78436735 Vaccine Group
n=27 Participants
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
|
|---|---|---|
|
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
|
85.2 percentage of participants
|
SECONDARY outcome
Timeframe: 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.
As assessed by medical records and or patient's report
Outcome measures
| Measure |
BNT162b2 Vaccine Group
n=30 Participants
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
|
JNJ-78436735 Vaccine Group
n=27 Participants
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
|
|---|---|---|
|
Proportion of Participants With a Positive COVID-19 Test
|
0 proportion of participants
|
0 proportion of participants
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
BNT162b2 Vaccine Group
n=30 Participants
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
|
JNJ-78436735 Vaccine Group
n=27 Participants
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
|
|---|---|---|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 0
|
30 Participants
|
27 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 2
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 5
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 6
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 7
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 8
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 9
|
0 Participants
|
0 Participants
|
|
Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale
WHO score of 10
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Number of Participants with vaccine-related adverse events as collected by the study team.
Outcome measures
| Measure |
BNT162b2 Vaccine Group
n=30 Participants
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
|
JNJ-78436735 Vaccine Group
n=27 Participants
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
|
|---|---|---|
|
Number of Participants With Vaccine-related Adverse Events
Local Reaction
|
9 Participants
|
6 Participants
|
|
Number of Participants With Vaccine-related Adverse Events
Systemic reaction
|
7 Participants
|
5 Participants
|
Adverse Events
BNT162b2 Vaccine Group
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
JNJ-78436735 Vaccine Group
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BNT162b2 Vaccine Group
n=30 participants at risk
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
|
JNJ-78436735 Vaccine Group
n=28 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arm pain
|
26.7%
8/30 • Number of events 9 • 6 months
|
17.9%
5/28 • Number of events 5 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
3.3%
1/30 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.3%
1/30 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Nervous system disorders
Headache
|
13.3%
4/30 • Number of events 4 • 6 months
|
21.4%
6/28 • Number of events 6 • 6 months
|
|
General disorders
Fatigue
|
13.3%
4/30 • Number of events 4 • 6 months
|
10.7%
3/28 • Number of events 3 • 6 months
|
|
General disorders
Fever
|
6.7%
2/30 • Number of events 2 • 6 months
|
7.1%
2/28 • Number of events 2 • 6 months
|
|
Eye disorders
Blurred Vision
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Reproductive system and breast disorders
Breast Pain
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Infections and infestations
Cellulitis
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
COVID19 Infection
|
16.7%
5/30 • Number of events 5 • 6 months
|
7.1%
2/28 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Gastroenteritis
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Renal and urinary disorders
Kidney Transplant Incision Abscess
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Gastrointestinal disorders
Lactic Acidosis
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
3.3%
1/30 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Poor Balance
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Post COVID Chronic Cough
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Syncytial Virus Pneumonia
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
6.7%
2/30 • Number of events 2 • 6 months
|
7.1%
2/28 • Number of events 2 • 6 months
|
|
Infections and infestations
Right Low Extremity Cellulitis
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Skin and subcutaneous tissue disorders
Seborreic Keratosis
|
3.3%
1/30 • Number of events 1 • 6 months
|
0.00%
0/28 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
3.3%
1/30 • Number of events 1 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/30 • 6 months
|
7.1%
2/28 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Bacterial Pneumonia
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Infections and infestations
Chills
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Chronic T-cell Mediated Rejection
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/30 • 6 months
|
7.1%
2/28 • Number of events 2 • 6 months
|
|
Nervous system disorders
Dizziness and Weakness
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Elevated Creatinine
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Essential Thrombocytosis
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
General disorders
Generalized Weakness
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Hypovolemia
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Leg Swelling
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Lower Extremities Edema
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Perinephric fluid collection
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Eye disorders
Pruritus/ eye redness
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Sepsis
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Renal and urinary disorders
Transplant Renal Artery Stenosis
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Tremors
|
0.00%
0/30 • 6 months
|
3.6%
1/28 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place