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ASPIRE - A Study Promoting the Influenza Response in the Elderly v1

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

Portfolio Eligibility
Automatically eligible
ISRCTN 24967173
EudraCT 2011-000092-13
MREC N° 11/H0406/10
UKCRN ID 10177
Research Summary
We intend to treat immunocompetent elderly individuals with the anti-viral drug valaciclovir in order to reduce the level of endogenous cytomegalovirus (CMV) replication. This is expected to subsequently reduce the magnitude of the CMV-specific immune response and therefore enhance immunity to other infections. This will be investigated by monitoring the immune response to influenza vaccination.
Study Type Interventional
Design Type Treatment
Disease(s) All Diseases
Phase IV
Current Status Open
Closure Date 12/31/2014
Global Sample Size 200
Global Recruitment to Date
Geographical Scope UK Multi-Centre
Lead Country England
Open to new sites Yes, within lead country only
Health care professionals can obtain a copy of the protocol by clicking here
Study Website
Main Inclusion Criteria
• Aged 65 years or above (30% 65-74 yrs old, 70% aged over 75 yrs).
• CMV seropositive.
• CMV-specific CD8+ and CD4+ T cell response over 0.5% of T cell pool at randomisation
• HLA type of HLA-A1, A2, B7 or B8.
• Predicted eGFR >50ml/min.
• LFT in normal range.
Main Exclusion Criteria
• On the following medication : Steroids, Ciclosporin, Mycophenolate, Probenecid, Tacrolimus, Theophylline.
• Significant chronic illness as assessed by clinical team.
• History of cardiovascular event in the last 6 months.
• GP considers inappropriate to take part
• Unable to provide written consent.
Chief Investigator(s)
Prof Paul Moss
Further details, please contact
Mr Joseph Bradley

University of Birmingham
Primary Care Clinical Sciences
School of Health and Population Sciences
West Midlands
B15 2TT

Tel: 0121 414 9116
Fax: 0121 414 3050
Funder(s) Medical Research Council (MRC)
Sponsor(s) University of Birmingham
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