The REnal Patients COVID-19 VACcination Immune Response (RECOVAC IR) Study

Summary

Rationale: COVID-19 is associated with severely increased morbidity and mortality in patients with severely impaired kidney function, on dialysis or alive with a kidney transplant. Therefore, effective SARS-CoV-2 vaccination would be of great clinical importance in these patients. However, SARS-CoV-2 vaccination studies have excluded patients with chronic kidney disease (CKD) so-far.

Objective: To assess the efficacy and safety of SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.

Study design: prospective, controlled multicenter study Study population: 175 patients with CKD stages 4/5 (eGFR \< 30 ml/min/1.73m2), 175 on dialysis , 300 alive with a kidney transplant and 200 controls (partners or sibblings of patients) Intervention: SARS-CoV-2 vaccination according to standard of care. Blood will be drawn at 4 different time points (baseline and at day 28, month 6 and in a subset 28 days after a third vaccination).

Main study parameters/endpoints: 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 based on a spike (S)1 specific antibody levels of \>=10 or \<10 BAU/mL. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group. 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. Other secondary endpoints include longevity of the immune response at 6 months, antibody respons 28 days after a third vaccination and levels of SARS-CoV-2 specific T and B cell responses.

Conditions

• Covid19
• Chronic Kidney Diseases

Interventions

BIOLOGICAL

SARS-CoV-2 vaccination

All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions.

Sponsors & Collaborators

• Erasmus Medical Center

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• University Medical Center Groningen

  lead OTHER

Principal Investigators

• Jan-Stephan F Sanders, MD PhD · University Medical Center Groningen

• Ron T Gansevoort, MD PhD · University Medical Center Groningen

• Luuk B Hilbrands, MD PhD · Radboud University Medical Center

• Marlies EJ Reinders, MD PhD · Erasmus Medical Center

• Frederike J Bemelman, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-02-17

Primary Completion

2021-06-04

Completion

2022-02-25

Countries

• Netherlands

Study Locations