Influence of Persistent CMV-Infection on Immune Senescence - Full Text View

Sponsors and Collaborators:	University of Zurich Division of Infectious Diseases and Hospital Epidemiology
Information provided by:	University of Zurich
ClinicalTrials.gov Identifier:	NCT00461695

Purpose

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.

Condition	Intervention	Phase
Immune Senescence	Biological: Vaccination against TBEV (FSME Immun CC)	Phase IV

MedlinePlus related topics: Cytomegalovirus Infections Encephalitis

Drug Information available for: Formaldehyde

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Efficacy Study
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)

Further study details as provided by University of Zurich:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Safety of TBEV-vaccination in healthy elderly individuals. [ Time Frame: One month after 3rd TBEV-vaccine administration. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00461695

Locations

Switzerland
Department of Infectious Diseases and Hospital Epidemiology
Zurich, Switzerland

Sponsors and Collaborators

University of Zurich

Division of Infectious Diseases and Hospital Epidemiology

Investigators

Study Director:

Studienregister MasterAdmins

UniversitaetsSpital Zuerich

More Information

Responsible Party:	Division of Infectious Diseases and Hospital Epidemiology, University of Zurich ( Urs Karrer, Professor, MD/PhD )
Study ID Numbers:	CYTEL-Protocol V1.A1
Study First Received:	April 17, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00461695
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:

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

Study placed in the following topic categories:

Central Nervous System Diseases
Formaldehyde
Healthy
Cytomegalovirus
Encephalitis
Tick-Borne Diseases
Encephalitis, Tick-Borne

Virus Diseases
Tick-borne encephalitis
Central Nervous System Infections
Cytomegalovirus Infections
Arbovirus Infections
Cytomegalic inclusion disease

Additional relevant MeSH terms:

Encephalitis, Viral
RNA Virus Infections
Flaviviridae Infections
Flavivirus Infections

Nervous System Diseases
Central Nervous System Viral Diseases
Encephalitis, Arbovirus

ClinicalTrials.gov processed this record on February 09, 2009