Influence of Persistent CMV-infection on Immune Senescence

NCT00461695 | Completed Phase 4

• 1 other identifier: CYTEL-Protocol V1.A1
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Senescence

Keywords

Cytomegalovirus (CMV); Tick-borne encephalitis virus (TBEV); Ageing; Vaccine; Immunity

Outcome Measures

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

  One month after each TBEV-vaccine administration

Secondary Outcomes (2)

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

  One month after 3rd TBEV-vaccine administration

• Safety of TBEV-vaccination in healthy elderly individuals.

  One month after 3rd TBEV-vaccine administration.

Study Arms (2)

CMV-seropositive

OTHER

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)

CMV-seronegative

OTHER

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)

Interventions

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.

CMV-seronegative; CMV-seropositive

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Division of Infectious Diseases and Hospital Epidemiology: collaborator

Study Sites (1)

University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology

Zurich, Switzerland

Location

Study Officials

• Urs Karrer, MD

  University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2007
• First Posted: April 18, 2007
• Study Start: May 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2010
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

CH (1)