Influence of Persistent CMV-infection on Immune Senescence

This study has been completed.
Sponsor:
Collaborator:
Division of Infectious Diseases and Hospital Epidemiology
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT00461695
First received: April 17, 2007
Last updated: August 26, 2013
Last verified: August 2013
  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: Allocation: Non-Randomized
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 ]

Enrollment: 183
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461695

Locations
Switzerland
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Division of Infectious Diseases and Hospital Epidemiology
Investigators
Principal Investigator: Urs Karrer, MD University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
  More Information

No publications provided

Responsible Party: 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: August 26, 2013
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 July 20, 2014