Influence of Persistent CMV-infection on Immune Senescence

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Immune Senescence

Treatments: Biological: Vaccination against TBEV (FSME Immun CC)

Study type: Interventional

Funder types: Other

Identifiers

NCT00461695

CYTEL-Protocol V1.A1

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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183 participants in 2 patient groups

CMV-seropositive

Other group

Description:

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.

Treatment:

Biological: Vaccination against TBEV (FSME Immun CC)

CMV-seronegative

Other group

Description:

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.

Treatment:

Biological: Vaccination against TBEV (FSME Immun CC)