Influence of Persistent CMV-Infection on Immune Senescence
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by University of Zurich.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Zurich
Collaborator:
Division of Infectious Diseases and Hospital Epidemiology
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00461695
First received: April 17, 2007
Last updated: June 5, 2008
Last verified: June 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Immune Senescence |
Biological: Vaccination against TBEV (FSME Immun CC) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| 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) |
Resource links provided by NLM:
Further study details as provided by University of Zurich:
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 [ Time Frame: One month after each TBEV-vaccine administration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Safety of TBEV-vaccination in healthy elderly individuals. [ Time Frame: One month after 3rd TBEV-vaccine administration. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 120 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Biological: 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| Ages Eligible for Study: | 70 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00461695
Locations
| Switzerland | |
| Department of Infectious Diseases and Hospital Epidemiology | |
| Zurich, Switzerland | |
Sponsors and Collaborators
University of Zurich
Division of Infectious Diseases and Hospital Epidemiology
Investigators
| Study Director: | Studienregister MasterAdmins | UniversitaetsSpital Zuerich |
More Information
No publications provided
| Responsible Party: | Urs Karrer, Professor, MD/PhD, Division of Infectious Diseases and Hospital Epidemiology, University of Zurich |
| ClinicalTrials.gov Identifier: | NCT00461695 History of Changes |
| Other Study ID Numbers: | CYTEL-Protocol V1.A1 |
| Study First Received: | April 17, 2007 |
| Last Updated: | June 5, 2008 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University of Zurich:
|
Cytomegalovirus (CMV) Tick-borne encephalitis virus (TBEV) Ageing Vaccine Immunity |
Additional relevant MeSH terms:
|
Cytomegalovirus Infections Encephalitis Encephalitis, Tick-Borne Herpesviridae Infections DNA Virus Infections Virus Diseases Central Nervous System Viral Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Central Nervous System Infections Encephalitis, Arbovirus Arbovirus Infections Tick-Borne Diseases Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 19, 2013