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Assessment of Immune Response After Vaccination Against COVID-19 in Patients Treated With Renal Replacement Therapy (COViNEPH-1)

3. Februar 2022 aktualisiert von: Leszek Tylicki, Medical University of Gdansk

Multi Center Study to Assess the Humoral and Cellular Response After Vaccination Against COVID-19 in Patients Treated With Renal Replacement Therapy

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  1. Venous blood samples will be collected at seven-time points: before dose 1 of vaccine, 21 days after dose 1, within 14-21 days after dose 2 and 3,6,9,12 months after vaccination. From the volume of about 8 ml of the patient's peripheral blood, a fraction of PBMC (peripheral blood mononuclear cells) will be isolated, which in the first stage of the study will be frozen in nitrogen. To generate serum, blood samples were centrifuged at room temperature at 2500 RPM for 10 minutes, aliquoted, frozen in -70˚C, and stored until use.
  2. The level of antibodies against the SARS-CoV-2 nucleocapsid (N) antigen will be detected in serum using the Abbot Architect™SARS-CoV-2 IgG test.
  3. The level of neutralizing IgG and IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S) will be detected in serum using the DiaSorin LIAISON®SARS-CoV-2 S1/S2 IgG serology COVID-19 S-Protein (S1RBD) Human IgA ELISA Kit respectively.
  4. The cellular component of the immune response will be tested using the ELISPOT method, which involves testing the amount of INF-γ and IL-2 released from leukocyte cells.
  5. The grading scales for side effects (the same as in the pivotal trial) used in this study were derived from the FDA Center for Biologics Evaluation and Research (CBER) guidelines on toxicity grading scales for healthy adult volunteers enrolled in preventive vaccine clinical trials.
  6. All medical data of patients from all groups will be extracted from their medical records.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

180

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Polen
      • Gdańsk, Polen
        • Rekrutierung
        • 7th Naval Hospital in Gdansk
        • Kontakt:
      • Gdynia, Polen
      • Gdynia, Polen
        • Rekrutierung
        • The University Centre of Maritime and Tropical Medicine in Gdynia
        • Kontakt:
    • Pomorskie
      • Gdansk, Pomorskie, Polen, 80-211
        • Rekrutierung
        • Medical University of Gdansk
        • Kontakt:
        • Unterermittler:
          • Bogdan P Biedunkiewicz, MD PhD
        • Unterermittler:
          • Alicja Dębska-Ślizień, MD PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients will be recruited in:

  1. Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk.
  2. NZOZ Diaverum Hemodialysis Unit in Gdynia.
  3. The University Centre of Maritime and Tropical Medicine in Gdynia
  4. 7th Naval Hospital in Gdansk

Beschreibung

Inclusion Criteria:

  • patients on chronic dialysis (hemodialysis or peritoneal dialysis) for at least 1 months and had received vaccination with mRNA vaccine BNT162b2 (BionTech/Pfizer Comirnaty) with a 3-week interval between first and second doses.

Exclusion Criteria:

  • (-)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Hemodialyzed patients
Hemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19
Diagnosetest: Immune response
  1. Venous blood samples will be collected at seven-time points: before dose 1 of vaccine, 21 days after dose 1, within 14-21 days after dose 2 and 3,6,9,12 months after vaccination. From the volume of about 8 ml of the patient's peripheral blood, a fraction of PBMC (peripheral blood mononuclear cells) will be isolated.
  2. The level of antibodies against the SARS-CoV-2 nucleocapsid (N) antigen will be detected in serum using the Abbot Architect™SARS-CoV-2 IgG test.
  3. The level of neutralizing IgG and IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S) will be detected in serum using the DiaSorin LIAISON®SARS-CoV-2 S1/S2 IgG serology COVID-19 S-Protein (S1RBD) Human IgA ELISA Kit respectively.
  4. The cellular component of the immune response will be tested using the ELISPOT method, which involves testing the amount of INF-γ and IL-2 released from leukocyte cells.
Sonstiges: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events
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
Patients treated with peritoneal dialysis
Patients treated with peritoneal dialysis vaccinated with BNT162b2 - mRNA vaccine against COVID-19
Diagnosetest: Immune response
  1. Venous blood samples will be collected at seven-time points: before dose 1 of vaccine, 21 days after dose 1, within 14-21 days after dose 2 and 3,6,9,12 months after vaccination. From the volume of about 8 ml of the patient's peripheral blood, a fraction of PBMC (peripheral blood mononuclear cells) will be isolated.
  2. The level of antibodies against the SARS-CoV-2 nucleocapsid (N) antigen will be detected in serum using the Abbot Architect™SARS-CoV-2 IgG test.
  3. The level of neutralizing IgG and IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S) will be detected in serum using the DiaSorin LIAISON®SARS-CoV-2 S1/S2 IgG serology COVID-19 S-Protein (S1RBD) Human IgA ELISA Kit respectively.
  4. The cellular component of the immune response will be tested using the ELISPOT method, which involves testing the amount of INF-γ and IL-2 released from leukocyte cells.
Sonstiges: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events
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
Patients without chronic kidney disease
Patients without chronic kidney disease vaccinated with mRNA BNT162b2 - vaccine against COVID-19
Diagnosetest: Immune response
  1. Venous blood samples will be collected at seven-time points: before dose 1 of vaccine, 21 days after dose 1, within 14-21 days after dose 2 and 3,6,9,12 months after vaccination. From the volume of about 8 ml of the patient's peripheral blood, a fraction of PBMC (peripheral blood mononuclear cells) will be isolated.
  2. The level of antibodies against the SARS-CoV-2 nucleocapsid (N) antigen will be detected in serum using the Abbot Architect™SARS-CoV-2 IgG test.
  3. The level of neutralizing IgG and IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S) will be detected in serum using the DiaSorin LIAISON®SARS-CoV-2 S1/S2 IgG serology COVID-19 S-Protein (S1RBD) Human IgA ELISA Kit respectively.
  4. The cellular component of the immune response will be tested using the ELISPOT method, which involves testing the amount of INF-γ and IL-2 released from leukocyte cells.
Sonstiges: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events
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
Kidney transplant recipients
Kidney transplant recipients vaccinated with mRNA vaccine against COVID-19
Diagnosetest: Immune response
  1. Venous blood samples will be collected at seven-time points: before dose 1 of vaccine, 21 days after dose 1, within 14-21 days after dose 2 and 3,6,9,12 months after vaccination. From the volume of about 8 ml of the patient's peripheral blood, a fraction of PBMC (peripheral blood mononuclear cells) will be isolated.
  2. The level of antibodies against the SARS-CoV-2 nucleocapsid (N) antigen will be detected in serum using the Abbot Architect™SARS-CoV-2 IgG test.
  3. The level of neutralizing IgG and IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S) will be detected in serum using the DiaSorin LIAISON®SARS-CoV-2 S1/S2 IgG serology COVID-19 S-Protein (S1RBD) Human IgA ELISA Kit respectively.
  4. The cellular component of the immune response will be tested using the ELISPOT method, which involves testing the amount of INF-γ and IL-2 released from leukocyte cells.
Sonstiges: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events
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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Humoral immune response
Zeitfenster: 12 months (7 time points)
Neutralizing IgG antibodies against the SARS-CoV (S1 and S2 subunits) (S)
12 months (7 time points)
Humoral immune response
Zeitfenster: 12 months (7 time points)
Neutralizing IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S)
12 months (7 time points)
The cellular immune response.
Zeitfenster: 12 months (7 time points)
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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Solicited and unsolicited local and systemic reactogenicity
Zeitfenster: Until 1 month after the second dose
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.
Until 1 month after the second dose

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Medical University of Gdansk

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

15. Februar 2021

Primärer Abschluss (Voraussichtlich)

31. August 2022

Studienabschluss (Voraussichtlich)

31. Dezember 2022

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Mai 2021

Zuerst gepostet (Tatsächlich)

28. Mai 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

4. Februar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Februar 2022

Zuletzt verifiziert

1. August 2021

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • COViNEPH-1

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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