Clinical trial NCT00461695: Influence of Persistent CMV-infection on Immune Senescence
Official title: Influence of Persistent CMV-infection on Immune Senescence Evaluated With a Prospective Vaccination Trial Against Tick-borne Encephalitis Virus in Healthy Elderly Individuals (CYTEL-Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Immune Senescence
Keywords: Cytomegalovirus (CMV)
Tick-borne encephalitis virus (TBEV)
Ageing
Vaccine
Immunity
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Division of Infectious Diseases and Hospital Epidemiology
First posted: 2007-04-18
Enrollment: 183
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: One month after each TBEV-vaccine administration
Secondary outcomes:
measure: Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test).
timeFrame: One month after 3rd TBEV-vaccine administration
measure: Safety of TBEV-vaccination in healthy elderly individuals.
timeFrame: One month after 3rd TBEV-vaccine administration.
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Study officials:
affiliation: University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
name: Urs Karrer, MD
role: PRINCIPAL_INVESTIGATOR
References: