Immune response after covid-19 vaccination in patients with renal failure stadium 4 or 5 .

Immune response after covid-19 vaccination in patients with renal failure stadium 4 or 5 . - RenalCoV

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000988-68-SE

Enrollment

Registered

2021-03-08

Start date

2021-03-31

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal failure stage 4 and 5.

Interventions

Trade Name: COVID-19 Vaccine AstraZeneca Product Name: COVID-19 Vaccine AstraZeneca Pharmaceutical Form: Suspension for injection Trade Name: Comirnaty Product Name: Comirnaty Pharmaceutical Form: Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult 18-65 years old. - Chronic renal failure stadium 4 or 5 with or without dialysis. - The study patient has given her/his consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: - Previous renal transplantation - Concomitant medication with immune-modulating agent - Current or previous known covid-19 infection at inclusion (i.e previous PCR positive for SARS-CoV-2 or previous detection of SARS-CoV-s antibodies). Antibodies detected during screening for this study is not an exclusion criterion. - Information in the Health declaration for covid-19 vaccination (17) which suggests that vaccination is inappropriate. - Vaccinated or planned vaccination with other vaccine within the next 14 days that can not be rescheduled. - Pregnancy - Hypersensitivity for any substance in the vaccine - Mental impairment, reluctance to participate or language difficulties which entail difficulties to understand the implication of the study - Individual who is not considered appropriate for study participation due to any other reason.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the proportion of patients with renal failure stadium 4 and 5, with or without dialysis, who have seroconverted 2 weeks after vaccine dose 2 or have at least 10^2 increase of neutralizing antibodies towards SARS-CoV-2 compared with baseline. ;Secondary Objective: - What proportion of patients with chronic renal failure stadium 4 or 5, with or without dialysis, have remaining immunity, i.e. continual detection of antibodies towards SARS-CoV-2, 3, 6 and 12 months after the second vaccine dose. -Difference in immune response before and two weeks after an extra/booster dose, if relevant - How common are side effects for covid-vaccination and what side effects occurs (AE/SAE/SUSAR);Primary end point(s): SARS-CoV-2 IgG directed towards the spike protein in blood collected before the vaccination and 2 weeks after the second vaccine dose. The analysis will be performed by ELISA.;Timepoint(s) of evaluation of this end point: Before vaccination (screening visit), Visit 2 (dose 2), Visit 3 (+14 days from dose 2) See table 1 in the study protocol.	—

Measure

Time frame

Main Objective: To investigate the proportion of patients with renal failure stadium 4 and 5, with or without dialysis, who have seroconverted 2 weeks after vaccine dose 2 or have at least 10^2 increase of neutralizing antibodies towards SARS-CoV-2 compared with baseline. ;Secondary Objective: - What proportion of patients with chronic renal failure stadium 4 or 5, with or without dialysis, have remaining immunity, i.e. continual detection of antibodies towards SARS-CoV-2, 3, 6 and 12 months after the second vaccine dose. -Difference in immune response before and two weeks after an extra/booster dose, if relevant - How common are side effects for covid-vaccination and what side effects occurs (AE/SAE/SUSAR);Primary end point(s): SARS-CoV-2 IgG directed towards the spike protein in blood collected before the vaccination and 2 weeks after the second vaccine dose. The analysis will be performed by ELISA.;Timepoint(s) of evaluation of this end point: Before vaccination (screening visit), Visit 2 (dose 2), Visit 3 (+14 days from dose 2) See table 1 in the study protocol.

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Secondary

Measure	Time frame
Secondary end point(s): - SARS-CoV-2 IgG and IgA will be measured in blood collected before the vaccination and at 4 other timepoints during one year after the second vaccine dose, and two weeks after an extra/booster dose if relevant - Epitope mapping of the antibody response as well as binding strength of the antibody may be evaluated. - Analysis for cellular immunity will be performed on an ongoing basis throughout the study and after all participants have been included. - The number of memory B-cells targeted towards the SARS-CoV-2 spike protein will be measured. - Memory B-cells may be sorted and genetic analysis (e.g. sequensing of the B cell receptor) may be carried out in order to examine how polyclonal and differentiated the humoral immune response is after vaccination. - The number of T cells targeted towards the SARS-CoV spike protein will be measured with in vitro stimulation with spike and with analysis of intracellular cytokine production. Polarisation of Th1 vs. Th2 response will be measured with the represenation of different cytokine profiles, e.g. IFN gamma vs IL-4. - Proportion of reported side effects (AE/SAE/SUSAR).;Timepoint(s) of evaluation of this end point: For SARS-CoV-2 IgG and IgA measurements: Visit 4 (+ 3 months from dose 2), Visit 5 (+ 6 months from dose 2), Visit 6 (+12 months from dose 2), and two weeks after an extra/booster dose if relevant (Extra visit 2). Cellular immunity is measured at all study visits except for visit 4 (3 months).	—

Measure

Time frame

Secondary end point(s): - SARS-CoV-2 IgG and IgA will be measured in blood collected before the vaccination and at 4 other timepoints during one year after the second vaccine dose, and two weeks after an extra/booster dose if relevant - Epitope mapping of the antibody response as well as binding strength of the antibody may be evaluated. - Analysis for cellular immunity will be performed on an ongoing basis throughout the study and after all participants have been included. - The number of memory B-cells targeted towards the SARS-CoV-2 spike protein will be measured. - Memory B-cells may be sorted and genetic analysis (e.g. sequensing of the B cell receptor) may be carried out in order to examine how polyclonal and differentiated the humoral immune response is after vaccination. - The number of T cells targeted towards the SARS-CoV spike protein will be measured with in vitro stimulation with spike and with analysis of intracellular cytokine production. Polarisation of Th1 vs. Th2 response will be measured with the represenation of different cytokine profiles, e.g. IFN gamma vs IL-4. - Proportion of reported side effects (AE/SAE/SUSAR).;Timepoint(s) of evaluation of this end point: For SARS-CoV-2 IgG and IgA measurements: Visit 4 (+ 3 months from dose 2), Visit 5 (+ 6 months from dose 2), Visit 6 (+12 months from dose 2), and two weeks after an extra/booster dose if relevant (Extra visit 2). Cellular immunity is measured at all study visits except for visit 4 (3 months).

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Countries

Sweden

Contacts

Public ContactInfektionskliniken

Region Örebro län

anja.rosdahl@regionorebrolan.se+460196021000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026