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Clinical Trials/ISRCTN24967173
ISRCTN24967173
Completed
Phase 2

A randomised controlled trial aimed at enhancing immunity to influenza in elderly individuals through reversal of immune senescence mediated by herpes virus infection

niversity of Birmingham (UK)0 sites700 target enrollmentAugust 17, 2011

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Topic: Primary Care Research Network for England, Inflammatory and Immune System
Sponsor
niversity of Birmingham (UK)
Enrollment
700
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 17, 2011
End Date
January 1, 2014
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Birmingham (UK)

Eligibility Criteria

Inclusion Criteria

  • 1\. Aged 65 years or above (30% 65\-74 yrs old, 70% aged over 75 yrs)
  • 2\. Cytomegalovirus (CMV) seropositive
  • 3\. CMV\-specific CD8\+ and CD4\+ T cell response over 0\.5% of T cell pool at randomisation
  • 4\. Human leuckocyte antigen (HLA) type of HLA\-A1, A2, B7 or B8
  • 5\. Predicted epidermal growth factor receptor (eGFR) \> 50ml/min
  • 6\. Liver function tests (LFT) in normal range
  • Target Gender: Male \& Female ; Lower Age Limit 65 years

Exclusion Criteria

  • 1\. On the following medication : Steroids, ciclosporin, mycophenolate, probenecid, tacrolimus, theophylline
  • 2\. Significant chronic illness as assessed by clinical team
  • 3\. History of cardiovascular event in the last 6 months
  • 4\. General practitoner (GP) considers inappropriate to take part
  • 5\. Unable to provide written consent

Outcomes

Primary Outcomes

Not specified

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