The efficacy and safety of COVID-19 vaccination in patients with a kidney disease

Phase 1

• Conditions: COVID-19 is associated with increased morbidity and mortality in kidney transplant recipients (KTR) and patients with chronic kidneydisease (CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would be of great clinical importance in these patients.However, SARS-CoV-2 vaccination studies have excluded KTR and patients with CKD so-far. This will be the subject of this trial.; MedDRA version: 20.0Level: LLTClassification code 10023438Term: Kidney transplantSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10061105Term: DialysisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; MedDRA version: 23.1Level: LLTClassification code 10084465Term: COVID-19 vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.1Level: LLTClassification code 10084401Term: COVID-19 respiratory infectionSystem Organ Class: 100000004862; MedDRA version: 23.1Level: LLTClassification code 10084464Term: COVID-19 immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 23.0Level: LLTClassification code 10084463Term: SARS-CoV-2 immunisationSystem Organ Class: 10042613 - Surgical and medical procedures

• Registration Number: EUCTR2021-000868-30-NL
• Lead Sponsor: RECOVAC consortium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-17
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 850

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
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 570
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 280

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified