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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 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

  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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

180

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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:

  • (-)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Hemodialyzed patients
Hemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19
Diagnostisk test: 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.
Andet: 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
Diagnostisk test: 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.
Andet: 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
Diagnostisk test: 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.
Andet: 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
Diagnostisk test: 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.
Andet: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Humoral immune response
Tidsramme: 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
Tidsramme: 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.
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Solicited and unsolicited local and systemic reactogenicity
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Medical University of Gdansk

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. februar 2021

Primær færdiggørelse (Forventet)

31. august 2022

Studieafslutning (Forventet)

31. december 2022

Datoer for studieregistrering

Først indsendt

27. maj 2021

Først indsendt, der opfyldte QC-kriterier

27. maj 2021

Først opslået (Faktiske)

28. maj 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. februar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. februar 2022

Sidst verificeret

1. august 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COViNEPH-1

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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