Influence of Persistent CMV-infection on Immune Senescence

Immune Senescence Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461695
• Other study ID #: CYTEL-Protocol V1.A1
• Status: Completed
• Phase: Phase 4
• First received: April 17, 2007
• Last updated: August 26, 2013
• Start date: May 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: December 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Encephalitis, Tick-Borne
• Immune Senescence

Intervention

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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Division of Infectious Diseases and Hospital Epidemiology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test).		One month after 3rd TBEV-vaccine administration	No
Secondary	Safety of TBEV-vaccination in healthy elderly individuals.		One month after 3rd TBEV-vaccine administration.	Yes