CMV QuantiFERON study

• Research type

  Research Study

• Full title

  Evaluation of the clinical usefulness of QuantiFERON®-CMV assay in identifying when patients reconstitute their immunity against Cytomegalovirus (CMV) after undergoing allogeneic HSCT. A prospective, non-randomised, open label study.

• IRAS ID

  321427

• Contact name

  Emanuela Pelosi

• Contact email

  Emanuela.Pelosi@uhs.nhs.uk

• Sponsor organisation

  University Hospital Southampton NHS Foundation Trust

• Duration of Study in the UK

  1 years, 0 months, 31 days

• Research summary

  Cytomegalovirus (CMV) is a pathogen of primary importance in the setting of transplantation, causing significant morbidity and mortality in haematopoietic stem cells transplant recipients, despite the progress achieved in terms of diagnostic investigations and antiviral treatment options over the past couple of decades.

  Our aim is to determine the clinical utility of a laboratory test that detects the interferon gamma (IFN-gamma) produced by CMV specific CD8+ cells, as surrogate marker of T-cell function to establish if patients have reconstituted the immunity to CMV when antiviral prophylaxis is discontinued. This knowledge would be of significant importance in order to identify the patients who are at risk for late CMV disease.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  23/LO/0366

• Date of REC Opinion

  2 May 2023

• REC opinion

  Favourable Opinion