Enhancing immunity to influenza in elderly individuals through reversal of immune senescence mediated by herpes virus infectio

Phase 2

Completed

• Conditions: Topic: Primary Care Research Network for England, Inflammatory and Immune System; Subtopic: Not Assigned, Inflammatory and Immune System (all Subtopics); Disease: Immunology and inflammation, All Diseases; Respiratory; Influenza due to other identified influenza virus

• Registration Number: ISRCTN24967173
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-08-17
• Study Completion: 2014-01-01
• Last Update Posted: 11 June 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The magnitude of the CMV-specific CD8+ T cell immune response.; Timepoint(s): Part One: Screening, Baseline, Months 1,2,3,4,5,6,9,12