The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant

The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant - The RECOVAC IR study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51071

Enrollment

850

Registered

2021-02-16

Start date

2021-02-17

Completion date

Unknown

Last updated

2024-04-09

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

Conditions

niertransplantatie, nieraandoeningen zowel in- als excl nefropathieen dialysis kidney insufficiency kidney transplantation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer. 2. Age of 18 years or older 3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained) 4. Either - CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI - Hemodialysis, or peritoneal dialysis - Kidney transplant recipient at least 6 weeks after transplantation - Partner, sibling, or other family member of participating patient with eGFR > 45 ml/min * 1,73 m2

Exclusion criteria

Exclusion criteria: -History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) toany component of the study intervention(s). -Multi-organ recipients -Previous or active COVID-19 disease -Active (haematological) malignancy -Inherited immune deficiency -Infection with Human Immunodeficency Virus (HIV) -Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders. The definition of response will be based on the latest available data from the pivotal studies and will be defined prior to data analyses and the first database lock. We will inform the METC about this definition and add this information to ClinicalTrials.gov. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group.	—

Measure

Time frame

The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as responders or non-responders. The definition of response will be based on the latest available data from the pivotal studies and will be defined prior to data analyses and the first database lock. We will inform the METC about this definition and add this information to ClinicalTrials.gov. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group.

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Secondary

Measure	Time frame
Other secondary endpoints include longevity of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs)graded according to severity.	—

Countries

Netherlands

Outcome results