Humoral and cellular immune response after vaccination in older people
Conditions
Interventions
Trade Name: Fluarix
Pharmaceutical Form: Suspension for injection in pre-filled syringe
Other descriptive name: INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED)
Concentration unit: mg milligram(s)
Concen
Sponsors
Katholieke Universiteit Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Older than 18 years ? written informed consent obtained ? CMV serostatus is known Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: ? Any contra-indication for influenza vaccination ? dementia (known minimental state examination (MMSE) < 15 ? palliative care ? medical emergency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare influenza humoral and cell-mediated vaccine response after influenza vaccination between CMV seropositive and CMV seronegative persons aged 65 years and older.;Secondary Objective: 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 ;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. ;Timepoint(s) of evaluation of this end point: Month 1 and 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) ;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) | — |
Countries
Belgium
Contacts
Public ContactClinical Trail Center
KU Leuven
Outcome results
None listed