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

NCT04905862 | Unknown

• 1 other identifier: COViNEPH-1
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 4

Brief 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 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.

Conditions

Kidney Failure, Chronic; Covid19; Vaccine Reaction; Vaccine Adverse Reaction

Keywords

COVID-19; Vaccine; Dialysis; Immunity; Kidney transplant recipient

Outcome Measures

Primary Outcomes (3)

• Humoral immune response

  Neutralizing IgG antibodies against the SARS-CoV (S1 and S2 subunits) (S)

  12 months (7 time points)

• Humoral immune response

  Neutralizing IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S)

  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

  12 months (7 time points)

Secondary Outcomes (1)

• Solicited and unsolicited local and systemic reactogenicity

  Until 1 month after the second dose

Study Arms (4)

Hemodialyzed patients

Hemodialyzed patients vaccinated with BNT162b2 - mRNA vaccine against COVID-19

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

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

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

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

Interventions

Immune response DIAGNOSTIC_TEST

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.

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 events OTHER

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

Hemodialyzed patients; Kidney transplant recipients; Patients treated with peritoneal dialysis; Patients without chronic kidney disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

• (-)

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (4)

Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, 80-211, Poland

RECRUITING

7th Naval Hospital in Gdansk

Gdansk, Poland

RECRUITING

NZOZ Diaverum Gdynia

Gdynia, Poland

RECRUITING

The University Centre of Maritime and Tropical Medicine in Gdynia

Gdynia, Poland

RECRUITING

Related Publications (1)

• 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.

  PMID: 35935974 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples collection.

MeSH Terms

Conditions

Kidney Failure, Chronic; COVID-19

Interventions

Immunity

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Central Study Contacts

Leszek Tylicki, MD PhD

CONTACT

0048583492830; leszek.tylicki@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: May 28, 2021
• Study Start: February 15, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 4, 2022

Record last verified: 2021-08

Locations

PL (4)