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

April 17, 2007
August 26, 2013
May 2007
August 2008   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00461695 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Influence of Persistent CMV-infection on Immune Senescence
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Immune Senescence
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-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.
    Intervention: Biological: Vaccination against TBEV (FSME Immun CC)
  • 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.
    Intervention: Biological: Vaccination against TBEV (FSME Immun CC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
183
December 2010
August 2008   (final data collection date for primary outcome measure)

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
Both
70 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00461695
CYTEL-Protocol V1.A1
No
University of Zurich
University of Zurich
Division of Infectious Diseases and Hospital Epidemiology
Principal Investigator: Urs Karrer, MD University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
University of Zurich
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP