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Trial participants became eligible to receive their 4th dose of the COVID-19 vaccine vaccine thus data collected from the 12 month follow-up after 3rd dose vaccine, as per current protocol, would not not be relevant to the study outcomes.
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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
| Unity Health Toronto | OTHER |
| Scarborough General Hospital | OTHER |
| Providence Healthcare |
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This study is a 12-month, four-arm parallel-group randomized control trial of Pfizer-BioNTech versus MODERNA COVID-19 (Corona Virus disease 2019)vaccine boosters in chronic kidney disease and dialysis patients with poor humoral response following COVID-19 vaccination, in collaboration with 5 dialysis centers in Ontario and British Columbia, Canada .
Patients will be randomized to MODERNA or Pfizer-BioNTech COVID-19 vaccine, they may have received either MODERNA or Pfizer-BioNTech COVID-19 vaccine for their initial two doses of vaccine, and will be stratified by their initial vaccine type (MODERNA or Pfizer-BioNTech ) prior to randomization, which will result in four study groups.
MODERNA : Nucleocapsid Modified messenger RNA BioNTech: Bio-Pharma new Technology
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who received two doses Pfizer-BioNTech vaccine, Arm 1 | Experimental |
| |
| Patients who received two doses MODERNA vaccine, Arm 2 | Experimental |
| |
| Patients who received two doses Pfizer-BioNTech vaccine ,Arm 3 | Experimental |
| |
| Patients who received two doses MODERNA vaccine, Arm 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pfizer-BioNTech COVID-19 Vaccine | Biological | This arm receives Pfizer-BioNTech COVID-19 Vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Level of Anti-RBD ( Anti Receptor Binding Domain ) | To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate. | One month |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Level of SARS-CoV-2 Antibodies | To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 3 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scarborough Health Network | Scarborough Village | Ontario | M1P 2V5 | Canada | ||
| University Health Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37847518 | Result | Yau K, Tam P, Chan CT, Hu Q, Qi F, Abe KT, Kurtesi A, Jiang Y, Estrada-Codecido J, Brown T, Liu L, Siwakoti A, Leis JA, Levin A, Oliver MJ, Colwill K, Gingras AC, Hladunewich MA. BNT162b2 versus mRNA-1273 Third Dose COVID-19 Vaccine in Patients with CKD and Maintenance Dialysis Patients. Clin J Am Soc Nephrol. 2024 Jan 1;19(1):85-97. doi: 10.2215/CJN.0000000000000328. Epub 2023 Oct 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Third Dose BNT162b2 | This group received BNT162b2 (Pfizer-BioNTech) as their third dose. |
| FG001 | Third Dose mRNA-1273 | This group received mRNA-1273 (Moderna) as their third dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Third Dose BNT162b2 | This group received BNT162b2 (Pfizer-BioNTech) as their third dose. |
| BG001 | Third Dose mRNA-1273 | This group received mRNA-1273 (Moderna) as their third dose |
| 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 | Serum Level of Anti-RBD ( Anti Receptor Binding Domain ) | To measure Anti-Spike, Anti-NP antibodies, and SARS-CoV-2 specific neutralization at 1 month (30 days) following third dose of vaccine (BNT162b2 versus mRNA-1273) binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate. | 7 participants withdrew from each arm and were not included in analysis. Only participants who provided samples for this timepoint were included in the analysis. | Posted | Mean | Standard Deviation | relative ratio | One month |
|
Deaths and serious adverse events were assessed for 6 months following 3rd dose and vaccine related (non-serious) adverse events were assessed over 2-14 days post-third dose.
All participants dosed were assessed for Deaths and Serious Adverse Events through self-report/review of EMR.
Other (non-serious) adverse events were systematically collected 2-14 days post third dose from participants who returned a questionnaire (129 from BNT162b2 and 126 from mRNA-1273).
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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 | Third Dose BNT162b2 | This group received BNT162b2 (Pfizer-BioNTech) as their third dose. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment | Local injection site reaction - Pain |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin Yau | University Health Network | 416 480 4592 | Kevin.Yau@uhn.ca |
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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 | Nov 5, 2021 | Dec 14, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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| OTHER |
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|
| MODERNA SARS-CoV-2 Vaccine | Biological | This arm receives MODERNA SARS-CoV-2 Vaccine |
|
|
| 3 months |
| Serum Level of SARS-CoV-2 Antibodies | To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 6 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate. | 6 months |
| Serum Level of SARS-CoV-2 Antibodies | Determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 12 months | 12 months |
| Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC) | In a subset of participants, assess cellular immunity through flow cytometry on PBMC and single-cell RNA sequencing prior to, one month, and 6 months following vaccine booster. | 1 month |
| Adverse Event | Evaluate adverse events related to third dose of vaccine through a questionnaire within 48 hours to 14 days following third vaccine dose. | 14 days |
| Adverse Events (30 Days) | Evaluate adverse events related to third dose of vaccine through a questionnaire at 30 days following third vaccine dose. | 1 month |
| Hospitalization | Number of participants who experienced COVID-19 related hospitalizations by study groups. | 6 months |
| COVID-19 Infections | Number of participants who experienced COVID-19 infections and symptomatic COVID-19 infections. | 6 months |
| Death | Differences in death between study groups. Death was collected for 6 months following third dose (shorted from 12 months due to the introduction of the 4th dose). | 6 months |
| Toronto |
| Ontario |
| M5G 2C4 |
| Canada |
| Sunnybrook Health Science Center | Toronto | Ontario | Canada |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Baseline two dose COVID-19 vaccine type | Count of Participants | Participants |
|
| Days between COVID-19 vaccine doses, median | Median | Inter-Quartile Range | Days |
|
| eGFR category | Count of Participants | Participants |
|
| Nondialysis CKD participants - eGFR by CKD-EPI | Non-dialysis CKD participants only | Median | Inter-Quartile Range | ml/min per 1.73 m2 |
|
| Nondialysis CKD participants - Microalbumin to creatinine ratio | Nondialysis CKD participants only | Mean | Standard Deviation | mg/mmol |
|
| Dialysis modality | Only applicable to dialysis patients | Count of Participants | Participants |
|
| Dialysis access | Only applicable for Dialysis patients | Count of Participants | Participants |
|
| Dialysis vintage | For dialysis patients only | Median | Inter-Quartile Range | years |
|
| Cause of kidney disease | Count of Participants | Participants |
|
| Prior COVID-19 infection | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
This group received mRNA-1273 (Moderna) as their third dose |
|
|
| Secondary | Serum Level of SARS-CoV-2 Antibodies | To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 3 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate. | 7 participants withdrew from each arm and were not included in analysis. Only participants who provided samples for this timepoint were included in the analysis. | Posted | Mean | Standard Deviation | relative ratios | 3 months |
|
|
|
| Secondary | Serum Level of SARS-CoV-2 Antibodies | To determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 6 months binding antibody levels for anti-receptor-binding domain and antispike IgG were reported as relative ratios to a synthetic standard included as a calibration curve on each assay plate. | 7 participants withdrew from each arm and were not included in analysis. Only participants who provided samples for this timepoint were included in the analysis. | Posted | Mean | Standard Deviation | relative ratios | 6 months |
|
|
|
| Secondary | Serum Level of SARS-CoV-2 Antibodies | Determine the effect of a third dose of COVID-19 vaccine on humoral immune response in hemodialysis patients through measurement of Anti-Spike, Anti-RBD, and Anti-NP antibodies at 12 months | Study was terminated before 12 months visit occurred. | Posted | 12 months |
|
|
| Secondary | Proportion of B and T-cell Lymphocyte Subsets in Peripheral Blood Mononuclear Cells (PBMC) | In a subset of participants, assess cellular immunity through flow cytometry on PBMC and single-cell RNA sequencing prior to, one month, and 6 months following vaccine booster. | Analysis on this subset was not feasible following study completion. The collaborating laboratory was unable to logistically perform this testing due to the resources required for Flow Cytometry, and therefore this secondary outcome was not analyzed. | Posted | 1 month |
|
|
| Secondary | Adverse Event | Evaluate adverse events related to third dose of vaccine through a questionnaire within 48 hours to 14 days following third vaccine dose. | Population consists of only individuals who returned the completed survey. | Posted | Count of Participants | Participants | 14 days |
|
|
|
| Secondary | Adverse Events (30 Days) | Evaluate adverse events related to third dose of vaccine through a questionnaire at 30 days following third vaccine dose. | We did not systematically collect symptoms at 30 days following vaccine dose, but rather 2-14 days only. This outcome was not analyzed. | Posted | 1 month |
|
|
| Secondary | Hospitalization | Number of participants who experienced COVID-19 related hospitalizations by study groups. | 7 participants withdrew from each arm | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | COVID-19 Infections | Number of participants who experienced COVID-19 infections and symptomatic COVID-19 infections. | 7 participants withdrew from each arm | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Death | Differences in death between study groups. Death was collected for 6 months following third dose (shorted from 12 months due to the introduction of the 4th dose). | excludes 7 participants that withdrew from each arm. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| 17 |
| 137 |
| 23 |
| 137 |
| 82 |
| 129 |
| EG001 | Third Dose mRNA-1273 | This group received mRNA-1273 (Moderna) as their third dose | 9 | 136 | 16 | 136 | 89 | 126 |
| Axillary abscess | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
|
| Cardiogenic shock | Cardiac disorders | Non-systematic Assessment |
|
| Colitis / Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Death, unspecified | General disorders | Non-systematic Assessment |
|
| End stage renal disease | Renal and urinary disorders | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hypervolaemia | Cardiac disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Ischaemic stroke | Vascular disorders | Non-systematic Assessment |
|
| Multiple myeloma | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Mycotic pseudoaneurysm of aorta | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Anema | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Cerebral haemorrhage | Vascular disorders | Non-systematic Assessment |
|
| Cerebral Infarction | Vascular disorders | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Myocardial infarction | Vascular disorders | Non-systematic Assessment |
|
| Peripheral swelling | Cardiac disorders | Non-systematic Assessment |
|
| Seizures | Nervous system disorders | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Steal phenomenon | Vascular disorders | Non-systematic Assessment |
|
|
| Redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Local injection site reaction - Redness |
|
| Swelling | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Local injection site reaction - Swelling |
|
| Fever (38 degrees) | Immune system disorders | Non-systematic Assessment |
|
| Chills | Immune system disorders | Non-systematic Assessment |
|
| Fatigue | Immune system disorders | Non-systematic Assessment |
|
| Nausea of vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| 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 |
| Anit-Spike |
|
| Anti-Spike |
|
| Swelling |
|
| Fever (38°C) |
|
| Chills |
|
| Fatigue |
|
| Nausea or vomiting |
|
| Diarrhea |
|
| Myalgia |
|
| Arthralgia |
|
| Headache |
|
| Any symptom |
|
| Any severe symptom |
|
| Any systemic symptom |
|
| Antipyretic medication |
|
| Confirmed cases of COVID-19 Infections with symptoms |
|
|