- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04905862
Assessment of Immune Response After Vaccination Against COVID-19 in Patients Treated With Renal Replacement Therapy (COViNEPH-1)
3. februar 2022 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
- 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.
- 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.
- 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.
- 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.
- 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.
- All medical data of patients from all groups will be extracted from their medical records.
Studietype
Observasjonsmessig
Registrering (Forventet)
180
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Leszek Tylicki, MD PhD
- Telefonnummer: 0048583492830
- E-post: leszek.tylicki@gumed.edu.pl
Studiesteder
-
-
-
Gdańsk, Polen
- Rekruttering
- 7th Naval Hospital in Gdansk
-
Ta kontakt med:
- Ewelina Puchalska-Reglińska, MD
- E-post: e.puchalska@7szmw.pl
-
Gdynia, Polen
- Rekruttering
- NZOZ Diaverum Gdynia
-
Ta kontakt med:
- Waldemar Ślizień, MD PhD
- E-post: waldemar.slizien@diaverum.com
-
Gdynia, Polen
- Rekruttering
- The University Centre of Maritime and Tropical Medicine in Gdynia
-
Ta kontakt med:
- Marcin Renke, MD PhD
- E-post: mrenke@gumed.edu.pl
-
-
Pomorskie
-
Gdansk, Pomorskie, Polen, 80-211
- Rekruttering
- Medical University of Gdansk
-
Ta kontakt med:
- Leszek Tylicki, MD PhD
- Telefonnummer: +48583492830
- E-post: leszek.tylicki@gumed.edu.pl
-
Underetterforsker:
- Bogdan P Biedunkiewicz, MD PhD
-
Underetterforsker:
- Alicja Dębska-Ślizień, MD PhD
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Patients will be recruited in:
- Department of Nephrology Transplantology and Internal Medicine, Medical University of Gdansk.
- NZOZ Diaverum Hemodialysis Unit in Gdynia.
- The University Centre of Maritime and Tropical Medicine in Gdynia
- 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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Hemodialyzed patients
Hemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19
|
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
|
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
|
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
|
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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. februar 2021
Primær fullføring (Forventet)
31. august 2022
Studiet fullført (Forventet)
31. desember 2022
Datoer for studieregistrering
Først innsendt
27. mai 2021
Først innsendt som oppfylte QC-kriteriene
27. mai 2021
Først lagt ut (Faktiske)
28. mai 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. februar 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. februar 2022
Sist bekreftet
1. august 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Coronavirus-infeksjoner
- Coronaviridae-infeksjoner
- Nidovirales infeksjoner
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Luftveisinfeksjoner
- Sykdommer i luftveiene
- Lungebetennelse, viral
- Lungebetennelse
- Lungesykdommer
- Nyresykdommer
- Urologiske sykdommer
- Nyresvikt, kronisk
- Covid-19
- Nyresvikt, kronisk
- Nyreinsuffisiens
- Fysiologiske effekter av legemidler
- Agenter fra det perifere nervesystemet
- Sensoriske systemagenter
- Analgetika
- Antipyretika
Andre studie-ID-numre
- COViNEPH-1
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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