Influence of Persistent CMV-infection on Immune Senescence
August 26, 2013 updated by: University of Zurich
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
183
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zurich, Switzerland
- University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: 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.
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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.
|
|
Other: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
Time Frame: One month after each TBEV-vaccine administration
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One month after each TBEV-vaccine administration
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test).
Time Frame: One month after 3rd TBEV-vaccine administration
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One month after 3rd TBEV-vaccine administration
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Safety of TBEV-vaccination in healthy elderly individuals.
Time Frame: One month after 3rd TBEV-vaccine administration.
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One month after 3rd TBEV-vaccine administration.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Urs Karrer, MD, University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
April 17, 2007
First Submitted That Met QC Criteria
April 17, 2007
First Posted (Estimate)
April 18, 2007
Study Record Updates
Last Update Posted (Estimate)
August 27, 2013
Last Update Submitted That Met QC Criteria
August 26, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYTEL-Protocol V1.A1
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