CMV modulation of the immune system in ANCA-associated vasculitis - v1

  • Research type

    Research Study

  • Full title

    Does CMV reactivation cause functional impairment of CMV specific CD4+ T-cells? The potential for valaciclovir to prevent CMV-mediated adverse modulation of the immune system in patients with ANCA-associated vasculitis

  • IRAS ID

    105579

  • Contact name

    Lorraine Harper

  • Sponsor organisation

    University of Birmingham

  • Eudract number

    2012-001970-28

  • Clinicaltrials.gov Identifier

    NCT01633476

  • Research summary

    Cytomegalovirus (CMV) is an almost ubiquitous virus that tends not to cause symptoms in healthy individuals. Research has shown that the virus remains in the body for life and undergoes periods of reactivation. The immune system tries to keep the virus in-check. However this means that a large proportion of T-cells, a part of the immune system important for fighting infection, are 'committed' to responding to CMV. Some of these committed T-cells do not appear to work well and can be described as dysfunctional. This is particularly evident in the elderly where previous CMV infection is linked with poor outcomes. Similar changes have been shown to occur in patients with autoimmune disease such as vasculitis. Vasculitis is a disease of the blood vessels that causes lung and kidney damage. CMV infection in these patients is linked with an increase in 'committed' T-cells. Furthermore this increase of dysfunctional ??committed?? T-cells is linked with an increased number of infections and mortality in vasculitis patients. This is crucial as infection is one of the leading causes of death amongst vasculitis patients. Funded by the Wellcome Trust and Vasculitis UK (the main UK vasculitis patient support group), this study will involve investigating the nature of CMV 'committed' T-cells and treating vasculitis patients with chronic CMV infection with an anti-CMV drug, valaciclovir. The main aim of the study is to determine whether treatment with valaciclovir reduces reactivation of the virus and as a result improves the function of 'committed?? T-cells. This in turn should lead to a better functioning immune system, potentially reducing the number of infections vasculitis patients get and improving survival. This may lead to improved therapy for vasculitis patients and also the ageing population with chronic CMV infection.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    12/YH/0377

  • Date of REC Opinion

    21 Aug 2012

  • REC opinion

    Further Information Favourable Opinion