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.
Conditions
Interventions
Product Name: Valaciclovir hydrochloride
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Valaciclovir Hydrochloride
CAS Number: 124832-27-5
Concentration unit: mg milligram(s)
Concentrati
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
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). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -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.;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.;Main Objective: 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. | — |
Countries
United Kingdom
Outcome results
None listed