Influence of Persistent CMV-infection on Immune Senescence
NCT ID: NCT00461695
Last Updated: 2013-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
183 participants
INTERVENTIONAL
2007-05-31
2010-12-31
Brief Summary
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Vaccination efficacy will be compared between CMV+ and CMV- individuals and correlated with the CMV-specific immune response in CMV+ individuals.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
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CMV-seropositive
Cytomegalovirus-seropositive individuals at screening (week 0). Intervention: Intervention: Vaccination against tick-borne encephalitis by 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.
Vaccination 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.
CMV-seronegative
Cytomegalovirus-seronegative individuals at screening (week 0). Intervention: Vaccination against tick-borne encephalitis by 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.
Vaccination 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.
Interventions
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Vaccination 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
ALL
No
Sponsors
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Division of Infectious Diseases and Hospital Epidemiology
UNKNOWN
University of Zurich
OTHER
Responsible Party
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Principal Investigators
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Urs Karrer, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Locations
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University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Zurich, , Switzerland
Countries
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Other Identifiers
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CYTEL-Protocol V1.A1
Identifier Type: -
Identifier Source: org_study_id