RENCOVAX study: SARS-CoV-2 vaccine response in kidney patients [COVID-19]

• Research type

  Research Study

• Full title

  RENCOVAX study: Evaluation of the response to the Covid-19 vaccine by assessment of spike protein antibodies to SARS-CoV-2 in patients with kidney disease on immunosuppression or on maintenance dialysis.

• IRAS ID

  295659

• Contact name

  Mysore Phanish

• Contact email

  m.phanish@nhs.net

• Sponsor organisation

  Epsom and St Helier University Hospitals NHS Trust

• Duration of Study in the UK

  0 years, 11 months, 28 days

• Research summary

  BACKGROUND
  The SARS-CoV-2 vaccination programme has been rolled out world-wide and at the time of this writing, more than 10 million people in the UK have received their first dose of vaccine. There is no published literature on vaccine response in patients with kidney disease and it is possible that they may not respond in a similar way to the general population due to their altered immune status and the immunosuppressive medication they may be taking.

  RATIONALE
  It is important to understand how kidney patients respond to the SARS-CoV-2 vaccine, in particular to see if there are differences in responses to the first and second doses of the vaccine. The data obtained will add to the existing body of knowledge and could be used to define any required changes to vaccine schedules in this population.

  RESEARCH QUESTION/AIM(S)
  Objectives

  1. To assess the baseline SARS-CoV-2 antibody (Nucleocapsid and Spike protein) status in patients on dialysis and patients with kidney disease on immunosuppression.
  2. To assess the vaccine response in dialysis patients and patients with kidney disease on immunosuppressive medication using a quantitative assay to measure antibodies against the spike protein of SARS-CoV-2.
  Primary objectives:
  1. To assess the response to the first dose of the vaccine (measured 3-12 weeks after the first dose).
  2. To assess the vaccine response following both doses of the vaccine (measured at 4-8 weeks and 12-20 weeks after the second dose of the vaccine).
  Secondary objective:
  To compare the vaccine response in patients who have had Covid-19 infection to those who have never had it.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  21/YH/0079

• Date of REC Opinion

  18 Mar 2021

• REC opinion

  Favourable Opinion