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Chronically dialyzed patients and kidney transplant recipients have been identified as particularly vulnerable to SARS-CoV-2 infection due to unavoidable exposure. They have also high rates of comorbid conditions and have varying degrees of immunosuppression, which puts them at risk of developing very severe forms of COVID-19 disease with fatality rates varying from 16% to 32%. In such circumstances vaccination is the only chance to improve their extremely poor prognosis. There is very little published data on the response to vaccination in dialyzed patients and kidney transplant recipients so far. No data are available on the efficacy of vaccines against COVID-19 in patients treated with peritoneal dialysis (PD). Furthermore, given the fact that disturbances of acquired immunity in dialyzed patients are many and diverse it is uncertain whether vaccinating against SARS CoV-2 in these population will result in sufficient immune response and, by consequence, protection against infection. Registration studies on the basis of which population vaccinations are actually conducted were performed only in the general population. There were no dialyzed patients and kidney transplant recipients in the study groups, so these patients are vaccinated with doses and schedules for people without chronic kidney disease. It is not known whether vaccination under such standard schedule produces a sufficient immune response in them and how long it lasts. That's why the aim of this study is to evaluate the humoral and cellular immune response after mRNA vaccine against COVID-19 with which patients treated with renal replacement therapy are vaccinated in Poland. It will be a prospective, observational controlled study conducted in patients treated with renal replacement therapy (hemodialyzed subjects, patients treated with peritoneal dialysis and kidney transplant recipients) vaccinated with mRNA vaccine against COVID-19 according to common rules and manufactures recommendations.The control group will be made up of sex and age matched people without chronic kidney disease.The first goal of the study is to analyze seroconversion rate and titer magnitude of neutralizing IgG and IgA antibodies directed against spike (s) SARS-CoV-2 antigen after the first and the second dose of mRNA vaccine as well as after 3, 6, 9, 12 months after vaccination. The second goal is to evaluate the cellular immune response tested using the ELISPOT method at the same time points as above.The immune response will be compared to patients without chronic kidney disease as well as between hemodialysis, peritoneal dialysis patients and kidney transplant recipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemodialyzed patients | Hemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19 |
| |
| Patients treated with peritoneal dialysis | Patients treated with peritoneal dialysis vaccinated with BNT162b2 - mRNA vaccine against COVID-19 |
| |
| Patients without chronic kidney disease | Patients without chronic kidney disease vaccinated with mRNA BNT162b2 - vaccine against COVID-19 |
| |
| Kidney transplant recipients | Kidney transplant recipients vaccinated with mRNA vaccine against COVID-19 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immune response | Diagnostic Test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immune response | Neutralizing IgG antibodies against the SARS-CoV (S1 and S2 subunits) (S) | 12 months (7 time points) |
| Humoral immune response | Neutralizing IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S) | 12 months (7 time points) |
| The cellular immune response. | Testing the amount of INF-γ and IL- 2 released from leukocyte cells in response to stimulation with S proteins | 12 months (7 time points) |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited and unsolicited local and systemic reactogenicity | Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events, i.e. those reported by the participants without prompts from the medical staff or observed by their physicians through 1 month after the second dose. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients will be recruited in:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leszek Tylicki, MD PhD | Contact | 0048583492830 | leszek.tylicki@gumed.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Gdansk | Recruiting | Gdansk | Pomeranian Voivodeship | 80-211 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35935974 | Derived | Piotrowska M, Zielinski M, Tylicki L, Biedunkiewicz B, Kubanek A, Slizien Z, Polewska K, Tylicki P, Muchlado M, Sakowska J, Renke M, Sudol A, Dabrowska M, Lichodziejewska-Niemierko M, Smiatacz T, Debska-Slizien A, Trzonkowski P. Local and Systemic Immunity Are Impaired in End-Stage-Renal-Disease Patients Treated With Hemodialysis, Peritoneal Dialysis and Kidney Transplant Recipients Immunized With BNT162b2 Pfizer-BioNTech SARS-CoV-2 Vaccine. Front Immunol. 2022 Jul 22;13:832924. doi: 10.3389/fimmu.2022.832924. eCollection 2022. |
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Venous blood samples collection.
|
| Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events | Other | The grading scales for side effects used in this study will derive from the FDA Center for Biologics Evaluation and Research guidelines on toxicity grading scales for volunteers enrolled in preventive vaccine clinical trials. Solicited reactions will be obtained 7 days after the first and the second dose, and 30 days after the final vaccination. Unsolicited adverse events and serious adverse events will be observed recorded through 1 month after the second dose |
|
| Until 1 month after the second dose |
| 7th Naval Hospital in Gdansk | Recruiting | Gdansk | Poland |
|
| NZOZ Diaverum Gdynia | Recruiting | Gdynia | Poland |
|
| The University Centre of Maritime and Tropical Medicine in Gdynia | Recruiting | Gdynia | Poland |
|
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| D007109 | Immunity |
| ID | Term |
|---|---|
| D055633 | Immune System Phenomena |
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