Immune SenescencePhase 4NCT00461695
Influence of Persistent CMV-infection on Immune Senescence
A Phase 4 study testing Vaccination against TBEV (FSME Immun CC) in people with Immune Senescence, run by University of Zurich at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Immune Senescence
- What is being tested?
- Vaccination against TBEV (FSME Immun CC)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
Zurich
About this 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)
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
- Being tested
- Vaccination against TBEV (FSME Immun CC)
- Keywords
- Cytomegalovirus (CMV), Tick-borne encephalitis virus (TBEV), Ageing, Vaccine, Immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Vaccination against TBEV (FSME Immun CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: One month after 3rd TBEV-vaccine administration
Safety of TBEV-vaccination in healthy elderly individuals.
Measured: One month after 3rd TBEV-vaccine administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SenescenceStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Division of Infectious Diseases and Hospital Epidemiology
- Responsible party
- Sponsor
- Investigators
- Urs Karrer, MD, Principal investigator, University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461695
- Sponsor's protocol ID
- CYTEL-Protocol V1.A1
- Status last verified
- Aug 2013
- First submitted
- 17 Apr 2007
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00461695
- Acronym / sponsor ID
- CYTEL-Protocol V1.A1
- Conditions
- Immune Senescence
- Keywords
- Cytomegalovirus (CMV), Tick-borne encephalitis virus (TBEV), Ageing, Vaccine, Immunity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Division of Infectious Diseases and Hospital Epidemiology
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 18 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMV-seropositive | Other | Biological: 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 | Other | Biological: 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | CMV-seronegative, CMV-seropositive |
Primary outcome
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
2 secondary outcomes
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
Safety of TBEV-vaccination in healthy elderly individuals.
Time frame: One month after 3rd TBEV-vaccine administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urs Karrer, MD principal investigator
University Hospital Zurich, Department of Infectious Diseases and Hospital Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vaccination against TBEV (FSME Immun CC) in people with Immune Senescence, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.