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Influence of Persistent CMV-infection on Immune Senescence

Primary Purpose

Immune Senescence

Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Vaccination against TBEV (FSME Immun CC)
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Immune Senescence focused on measuring Cytomegalovirus (CMV), Tick-borne encephalitis virus (TBEV), Ageing, Vaccine, Immunity

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

CMV-seropositive

CMV-seronegative

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test).
Safety of TBEV-vaccination in healthy elderly individuals.

Full Information

First Posted
April 17, 2007
Last Updated
August 26, 2013
Sponsor
University of Zurich
Collaborators
Division of Infectious Diseases and Hospital Epidemiology
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1. Study Identification

Unique Protocol Identification Number
NCT00461695
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Division of Infectious Diseases and Hospital Epidemiology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Senescence
Keywords
Cytomegalovirus (CMV), Tick-borne encephalitis virus (TBEV), Ageing, Vaccine, Immunity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CMV-seropositive
Arm Type
Other
Arm Description
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.
Arm Title
CMV-seronegative
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Vaccination against TBEV (FSME Immun CC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Safety of TBEV-vaccination in healthy elderly individuals.
Time Frame
One month after 3rd TBEV-vaccine administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urs Karrer, MD
Organizational Affiliation
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
City
Zurich
Country
Switzerland

12. IPD Sharing Statement

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Influence of Persistent CMV-infection on Immune Senescence

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