Kidney Failure, ChronicCOViNEPH-1NCT04905862
Assessment of Immune Response After Vaccination Against COVID-19 in Patients Treated With Renal Replacement Therapy
An observational study of Kidney Failure, Chronic and Covid19, run by Medical University of Gdansk at 4 sites in Poland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Covid19, Vaccine Reaction
- What is being tested?
- Immune response and Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events
- Type of treatment
- Vaccines
- How many people
- 180 participants
- Where
- 4 sitesPoland
- Study dates
- 15 Feb 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- (-)
Trial locations and contacts
4 sites in 1 country.
Poland4 sites, 4 recruiting
- Recruiting
Medical University of Gdansk
Gdansk, Pomeranian Voivodeship, 80-211
Leszek Tylicki, MD PhD, +48583492830, leszek.tylicki@gumed.edu.pl
Bogdan P Biedunkiewicz, MD PhD
- Recruiting
7th Naval Hospital in Gdansk
Gdansk
Ewelina Puchalska-Reglińska, MD, e.puchalska@7szmw.pl
- Recruiting
NZOZ Diaverum Gdynia
Gdynia
Waldemar Ślizień, MD PhD, waldemar.slizien@diaverum.com
- Recruiting
The University Centre of Maritime and Tropical Medicine in Gdynia
Gdynia
Marcin Renke, MD PhD, mrenke@gumed.edu.pl
About this study
Official title: 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.
Read the detailed description
- 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.
- Being tested
- Immune response, Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events
- Keywords
- COVID-19, Vaccine, Dialysis, Immunity, Kidney transplant recipient
- Medical subject headings
- Kidney Failure, Chronic, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immune responseDiagnostic test
- 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.
- 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.
Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse eventsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hemodialyzed patients | Hemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19 Receives: Diagnostic Test: Immune response; Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events | |
| Patients treated with peritoneal dialysis | Patients treated with peritoneal dialysis vaccinated with BNT162b2 - mRNA vaccine against COVID-19 Receives: Diagnostic Test: Immune response; Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events | |
| Patients without chronic kidney disease | Patients without chronic kidney disease vaccinated with mRNA BNT162b2 - vaccine against COVID-19 Receives: Diagnostic Test: Immune response; Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events | |
| Kidney transplant recipients | Kidney transplant recipients vaccinated with mRNA vaccine against COVID-19 Receives: Diagnostic Test: Immune response; Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral immune response
Neutralizing IgG antibodies against the SARS-CoV (S1 and S2 subunits) (S)
Measured: 12 months (7 time points)
Humoral immune response
Neutralizing IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S)
Measured: 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
Measured: 12 months (7 time points)
Secondary outcomes (1)
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.
Measured: Until 1 month after the second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start15 Feb 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leszek Tylicki, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905862
- Sponsor's protocol ID
- COViNEPH-1
- Acronym
- COViNEPH-1
- Status last verified
- Aug 2021
- First submitted
- 27 May 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35935974
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center Study to Assess the Humoral and Cellular Response After Vaccination Against COVID-19 in Patients Treated With Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT04905862
- Acronym / sponsor ID
- COViNEPH-1 / COViNEPH-1
- Keywords
- COVID-19, Vaccine, Dialysis, Immunity, Kidney transplant recipient
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hemodialyzed patients | – | Diagnostic Test: Immune response, Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse eventsHemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19 |
| Patients treated with peritoneal dialysis | – | Diagnostic Test: Immune response, Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse eventsPatients treated with peritoneal dialysis vaccinated with BNT162b2 - mRNA vaccine against COVID-19 |
| Patients without chronic kidney disease | – | Diagnostic Test: Immune response, Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse eventsPatients without chronic kidney disease vaccinated with mRNA BNT162b2 - vaccine against COVID-19 |
| Kidney transplant recipients | – | Diagnostic Test: Immune response, Other: Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse eventsKidney transplant recipients vaccinated with mRNA vaccine against COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- (-)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immune response1. 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. | Diagnostic test | Hemodialyzed patients, Kidney transplant recipients, Patients treated with peritoneal dialysis, Patients without chronic kidney disease |
| Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse eventsThe 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 | Other | Hemodialyzed patients, Kidney transplant recipients, Patients treated with peritoneal dialysis, Patients without chronic kidney disease |
Primary outcome
Humoral immune response
Time frame: 12 months (7 time points)
Neutralizing IgG antibodies against the SARS-CoV (S1 and S2 subunits) (S)
Humoral immune response
Time frame: 12 months (7 time points)
Neutralizing IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S)
The cellular immune response.
Time frame: 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
1 secondary outcome
Solicited and unsolicited local and systemic reactogenicity
Time frame: Until 1 month after the second dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Derived from this study: PubMed 35935974Piotrowska 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Covid19, run by Medical University of Gdansk at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leszek Tylicki, MD PhD (0048583492830, leszek.tylicki@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immune response (time frame: 12 months (7 time points)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04905862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.