Immune Senescence
Conditions
Keywords
Cytomegalovirus (CMV), Tick-borne encephalitis virus (TBEV), Ageing, Vaccine, Immunity
Brief summary
Recent studies indicate that persistent viral infections particularly with Cytomegalovirus (CMV) might have a negative impact on immune senescence (i.e. immunocompetence of elderly individuals). We will test this hypothesis by performing a vaccination trial in healthy elderly individuals subdivided in two groups of CMV-seropositive and CMV-seronegative individuals. All individuals will be vaccinated with the currently licensed vaccine for the prevention of TBE (FSME Immun CC) which is recommended for the general population in our area. Vaccination efficacy will be monitored longitudinally concerning the TBEV-specific antibody (TBEV-neutralization, TBEV-specific ELISA) and T cell response (ELISpot, cytokine production). Vaccination efficacy will be compared between CMV+ and CMV- individuals and correlated with the CMV-specific immune response in CMV+ individuals.
Interventions
BIOLOGICALVaccination against TBEV (FSME Immun CC)
Intramuscular injection into the left (or right) deltoid muscle of 0.5 ml FSME Immun CC for adults (2.4 ug of formalin inactivated TBEV antigen) at time point 0, after 4 weeks and after 24 weeks.
Sponsors
Division of Infectious Diseases and Hospital Epidemiology
University of Zurich
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 70 years * Healthy according to a health questionnaire (completed before screening) * TBE-Vaccination indicated (exposure to TBEV-infested ticks possible) * Capable to make an informed decision and to understand the informed consent form * Informed consent signed by patient and study physician
Exclusion criteria
* Previous exposure to TBEV (natural or vaccination) * Immunodeficiency, history of autoimmune disease or current intake of immune-modulating drugs (corticosteroids a.s.o.) * Persistent (\> 3 months) pharmacological treatment with more than one drug of relevance (exception: combination antihypertensives) * Contraindication for TBEV-vaccination * Condition that would drastically interfere with clinic attendance and/or adherence to the protocol * Past medical history or current treatment for one of the following conditions: Chronic cardiac disease (Coronary heart disease, heart failure), chronic pulmonary disease (COPD), chronic kidney disease, diabetes mellitus, previous stroke, epilepsy, Parkinsons disease, dementia * Hemoglobin \<12 g/l * Random plasma glucose (RPG) \> 11.1 mmol/l OR fasting plasma glucose (FPG) \> 6.9 mmol/l (FPG required, if RPG is 7.0-11.0 mmol/l) * Calculated Creatinin-Clearance \< 50 ml/min * TBEV-serology positive
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT) of anti-TBEV-antibodies measured by TBEV-neutralisation assay and ELISA one month after each TBEV-vaccine administration in the group of CMV-seropositive versus CMV-seronegative individuals | One month after each TBEV-vaccine administration |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test). | One month after 3rd TBEV-vaccine administration |
| Safety of TBEV-vaccination in healthy elderly individuals. | One month after 3rd TBEV-vaccine administration. |
Countries
Switzerland
Outcome results
None listed