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Completed

NCT Number: NCT00461695

Influence of Persistent CMV-infection on Immune Senescence

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.

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Key information

Conditions

Immune Senescence

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vaccination against TBEV (FSME Immun CC)

Biological

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 outcomes

  1. 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 outcomes

  1. 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

  2. Safety of TBEV-vaccination in healthy elderly individuals.

    Time frame: One month after 3rd TBEV-vaccine administration.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Division of Infectious Diseases and Hospital Epidemiology

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2008
Study completion
2010
First posted
Apr 18, 2007
Registry last updated
Aug 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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