E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Humoral and cellular immune response after vaccination in older people |
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E.1.1.1 | Medical condition in easily understood language |
Antibodies and cell-mediated immune response after vaccination in older people |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
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 |
To compare influenza humoral and cell-mediated vaccine response after influenza vaccination between CMV seropositive and CMV seronegative persons aged 65 years and older. |
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E.2.2 | Secondary objectives of the trial |
1. To investigate how humoral and cell-mediated immune response after influenza vaccination relate to each other in elderly. 2. To assess and compare between CMV seronegatives and CMV seropositives the B cell count, frequency of CD4+ and CD8+ T cells, CD4+/CD8+ ratio, T cell subset analysis and frequency and type of CMV specific T cells and to investigate how these relate to influenza vaccination response. 3. To assess and compare between CMV seronegatives and CMV seropositives the inflammatory profile and to investigate how the inflammatory profile affects the immune response after influenza vaccination 4. To compare the incidence of influenza like illness and complications arising from it in CMV seropositives and CMV seronegatives 5. To assess CMV viral DNA in peripheral monocytes and the relationship of detectable CMV DNA with cell-mediated and humoral immune response after influenza vaccination 6. To assess the incidence of CMV reactivation and its determinants
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
➢ Older than 18 years ➢ written informed consent obtained ➢ CMV serostatus is known
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E.4 | Principal exclusion criteria |
➢ Any contra-indication for influenza vaccination ➢ dementia (known minimental state examination (MMSE) < 15 ➢ palliative care ➢ medical emergency |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are: • Humoral immune response to influenza vaccination as expressed by seroconversion or a four-fold increase of anti-hemagglutinin (HI) antibody titers. • Cellular immune response to influenza vaccination as expressed by the measurement of cytokines and granzyme B activity produced by peripheral blood mononuclear cells (PBMCs) after ex vivo stimulation with influenza virus antigens.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- CMV-DNA (PCR) in monocytes as a marker of persistent infection. - CMV-DNA (PCR) in urine as a marker of reactivation. - RT-PCR results of nasal swab samples as influenza infection - Frequency of B- and T-cell subsets (flow cytometry) - CMV-specific cytokine production (intracytoplasmatic cytokine) as level of CMV-induced CTL-activity, - Prevalence of different CMV-specific T cell subsets (Flow cytometry and TERT assay) - Cytokines levels as inflammatory profile (multiplex assay)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For blood analyses: month 1 and 3 For urine analyses: week 1 to 24 and month 6 and 12 For nasal swab analyses: if occurrence of influenza-like illness (weekly phonecall) |
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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 | No |
E.6.4 | Safety | No |
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 | No |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
CMV infection and Age-stratified |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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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last visit of the last subject undergoing the trial |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |