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

3. února 2022 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

  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.

Typ studie

Pozorovací

Zápis (Očekávaný)

180

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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

Popis

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:

  • (-)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
Hemodialyzed patients
Hemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19
Diagnostický 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.
Jiný: 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
Diagnostický 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.
Jiný: 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
Diagnostický 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.
Jiný: 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
Diagnostický 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.
Jiný: 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

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Humoral immune response
Časové okno: 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
Časové okno: 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.
Časové okno: 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)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Solicited and unsolicited local and systemic reactogenicity
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Medical University of Gdansk

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. února 2021

Primární dokončení (Očekávaný)

31. srpna 2022

Dokončení studie (Očekávaný)

31. prosince 2022

Termíny zápisu do studia

První předloženo

27. května 2021

První předloženo, které splnilo kritéria kontroly kvality

27. května 2021

První zveřejněno (Aktuální)

28. května 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. února 2022

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. února 2022

Naposledy ověřeno

1. srpna 2021

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • COViNEPH-1

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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