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Difficulty in recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BNT162b2 vaccine Group | Experimental | Participants in this arm will receive one booster dose of the BNT162b2. |
|
| JNJ-78436735 vaccine Group | Experimental | Participants in this arm will receive one booster dose of the JNJ-78436735 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BNT162b2 vaccine | Biological | Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 1 month (post booster vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With a Positive COVID-19 Test | As assessed by medical records and or patient's report | Up to 1 month (post third dose) |
| Number of Participants With COVID-19 Symptom Severity as Measured by the WHO Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giselle Guerra, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39798807 | Derived | Natori Y, Martin E, Mattiazzi A, Arosemena L, Burke GW, Munagala MR, Manickavel S, Sota K, Pallikkuth S, Chen J, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. Post hoc analysis: 6 Months immunogenicity after third dose of BNT162b2 vs JNJ-78,436,735 after two doses of BNT162b2 vaccine in solid organ transplant recipients. Immunol Lett. 2025 Jun;273:106968. doi: 10.1016/j.imlet.2024.106968. Epub 2025 Jan 9. | |
| 37091963 |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | JNJ-78436735 Vaccine Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | Number | percentage of participants | Up to 1 month (post booster vaccination) |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giselle Guerra | University of Miami | 3053555803 | gguerra@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2022 | Apr 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| D000090984 | Ad26COVS1 |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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| JNJ-78436735 Vaccine | Biological | Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle |
|
World Health Organization (WHO) scale is scored between from 0 -10.
0: Uninfected; non-viral Ribonucleic Acid (RNA) detected
| Up to 1 month (post third dose) |
| Number of Participants With Vaccine-related Adverse Events | Number of Participants with vaccine-related adverse events as collected by the study team. | Up to 7 days (post third dose) |
| Derived |
| Natori Y, Martin E, Mattiazzi A, Arosemena L, Ortigosa-Goggins M, Shobana S, Roth D, Kupin WL, Burke GW, Ciancio G, Morsi M, Phancao A, Munagala MR, Butrous H, Manickavel S, Sinha N, Sota K, Pallikkuth S, Bini J, Simkins J, Anjan S, Vianna RM, Guerra G. A Pilot Single-Blinded, Randomized, Controlled Trial Comparing BNT162b2 vs. JNJ-78436735 Vaccine as the Third Dose After Two Doses of BNT162b2 Vaccine in Solid Organ Transplant Recipients. Transpl Int. 2023 Apr 5;36:10938. doi: 10.3389/ti.2023.10938. eCollection 2023. |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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 |
|
|
| Secondary | Proportion of Participants With a Positive COVID-19 Test | As assessed by medical records and or patient's report | 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. | Posted | Number | proportion of participants | Up to 1 month (post third dose) |
|
|
|
| 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
| 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. | Posted | Count of Participants | Participants | Up to 1 month (post third dose) |
|
|
|
| Secondary | Number of Participants With Vaccine-related Adverse Events | Number of Participants with vaccine-related adverse events as collected by the study team. | 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. | Posted | Count of Participants | Participants | Up to 7 days (post third dose) |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 13 |
| 30 |
| EG001 | 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 | 0 | 28 | 0 | 28 | 20 | 28 |
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
|
| Acute Kidney Injury | Renal and urinary disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Breast Pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| COVID19 Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Kidney Transplant Incision Abscess | Renal and urinary disorders | Systematic Assessment |
|
| Lactic Acidosis | Gastrointestinal disorders | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Poor Balance | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Post COVID Chronic Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory Syncytial Virus Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Right Low Extremity Cellulitis | Infections and infestations | Systematic Assessment |
|
| Seborreic Keratosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sore Throat | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bacterial Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chills | Infections and infestations | Systematic Assessment |
|
| Chronic T-cell Mediated Rejection | Blood and lymphatic system disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness and Weakness | Nervous system disorders | Systematic Assessment |
|
| Elevated Creatinine | Renal and urinary disorders | Systematic Assessment |
|
| Essential Thrombocytosis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Generalized Weakness | General disorders | Systematic Assessment |
|
| Hypovolemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Leg Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Lower Extremities Edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Perinephric fluid collection | Blood and lymphatic system disorders | Systematic Assessment |
|
| Pruritus/ eye redness | Eye disorders | Systematic Assessment |
|
| Sepsis | Blood and lymphatic system disorders | Systematic Assessment |
|
| Transplant Renal Artery Stenosis | Renal and urinary disorders | Systematic Assessment |
|
| Tremors | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |
| WHO score of 2 |
|
| WHO score of 3 |
|
| WHO score of 4 |
|
| WHO score of 5 |
|
| WHO score of 6 |
|
| WHO score of 7 |
|
| WHO score of 8 |
|
| WHO score of 9 |
|
| WHO score of 10 |
|