Influence of Persistent CMV-infection on Immune Senescence

Phase 4

Completed

• Conditions: Immune Senescence
• Interventions: Biological: Vaccination against TBEV (FSME Immun CC)

• Registration Number: NCT00461695
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-04-17
• Study First Submitted QC: 2007-04-17
• Study First Posted: 2007-04-18
• Study Start: 2007-05
• Primary Completion: 2008-08
• Study Completion: 2010-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-26
• Last Update Posted: 2013-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CMV-seropositive	Vaccination against TBEV (FSME Immun CC)	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.
CMV-seronegative	Vaccination against TBEV (FSME Immun CC)	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety of TBEV-vaccination in healthy elderly individuals.	One month after 3rd TBEV-vaccine administration.
Efficacy of TBEV-vaccination in healthy elderly individuals (Geometric mean antibody titer measured by TBEV-neutralisation test).	One month after 3rd TBEV-vaccine administration

Trial Locations

Locations (1)

University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology; 🇨🇭 Zurich, Switzerland