E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial is aimed to improve the efficiency of the seasonal influenza vaccine. Healthy volunteers who are positive for cytomegalovirus (CMV) will be recruited and given anti-viral treatment. We hypothesise that this will reduce their viral load and thereby reduce the proportion of T cells committed to CMV. This will then facilitate the development of an optimal response against the influenza vaccine. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Part 1 : Feasibilty Study -The primary objective is to determine the efficacy of valaciclovir for reduction of the CMV-specific T cell response. Part 2 : Phase II Randomised Controlled Trial -The primary objective is to assess the value of valaciclovir in the augmentation of the immune response to influenza vaccination in donors aged ≥65 years. |
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E.2.2 | Secondary objectives of the trial |
-Document to optimal dosage and duration of therapy to reduce the CMV-specific immune response. -Determine how therapy influences serum level of cytokine and inflammatory markers. -Elucidate the kinetics of change in the CMV-specific immune response during and after the treatment course. -Assess if treatment can reduce the level of viral excretion in elderly donors. -Determine how therapy alters the level of viral load and virus-specific immune response against the other members of the human herpesvirus family. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria will be aged 65 years or above, CMV seropositive, a T cell response of over 0.5% at randomisation, relevant HLA-type, good renal function (eGFR>50ml/min). |
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E.4 | Principal exclusion criteria |
Exclusion criteria will include unable to provide consent, on medication that may alter immune function, significant chronic illness as assessed by clinical team as this could affect ability to cooperate with the trial and may alter immune competence, history of a cardiovascular event in the past 6 months, and if the GP considers inappropriate to take part. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Part 1 : Feasibilty Study -The magnitude of the CMV-specific CD4+ T cell immune response. -The magnitude of the CMV-specific CD8+ T cell immune response. -The titre of the CMV-specific antibody response. -The CMV viral load in urine. Part 2 : Phase II RCT -The improvement in the proportion of individuals making an adequate response to a seasonal influenza vaccination. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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For the purposes of Clinical Trial Authorisation (CTA) under the European Union Directive 2001/20/EC, the study is deemed to have ended 30 days after the last patient receives the last dose of the Investigational Medicinal Product (IMP). For the purposes of Multicentre Research Ethics Committee approval, the study end date is deemed to be the date of last data capture. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |