Tick-borne EncephalitisPhase 4NCT00804219
Humoral and Cellular Immunity of Low and High-responders After Tick-borne Encephalitis Vaccination
A Phase 4 study testing TBE vaccination and influenza vaccination in people with Tick-borne Encephalitis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees. The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tick-borne Encephalitis
- What is being tested?
- TBE vaccination and influenza vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2008to Nov 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (≥18 years) of both sexes without upper age limit
- Willingness to sign written informed consent form
- Basic vaccination plus one booster (minimum) of TBE-vaccine,
Who cannot join
- Age: < 18 years
- Pregnancy or breast feeding
- Prior TBE infection
- Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study
- Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study
- History of autoimmune disease
Show all 13Show fewer
- Drug addiction
- Plasma donators
- Administration of other vaccines 4 weeks before/after day 0
- Administration of immunoglobulins 6 weeks prior to any vaccination or blood donation during the entire study period
- Specific Immune Therapy (Hypo-/Desensibilization) within 14 days before and after the 2 study vaccination doses.
- History of any malignant disease 5 years prior to the study entry
- Any contraindication for the administration of the TBE- or influenza vaccine according to the manufactures information.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute of Specific Prophylaxis and Tropical Medicine
Vienna, State of Vienna, 1090
About this study
Official title: Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination
The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.
The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.
- Conditions
- Tick-borne Encephalitis
- Being tested
- TBE vaccination and influenza vaccination
- Keywords
- low responsiveness after vaccination
- Medical subject headings
- Encephalitis, Tick-Borne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TBE vaccination and influenza vaccinationBiological
Also called FSME-Immun ATC code: J07 BA1, Inflexal ATC code: J07 BB02
FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x
| Study group | Role | What they receive |
|---|---|---|
| TBE low responder | Experimental | Not described Receives: Biological: TBE vaccination and influenza vaccination |
| FSME responder | Experimental | Not described Receives: Biological: TBE vaccination and influenza vaccination |
| hepatitis B non-responder | Experimental | Not described Receives: Biological: TBE vaccination and influenza vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
Measured: 7 days after TBE-booster plus influenza vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tick-borne EncephalitisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ursula Wiedermann-Schmidt, MD, PhD, Principal investigator, Institute of Specific Prophylaxis and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804219
- Sponsor's protocol ID
- FSME low-responder 1.1
- Other IDs
- EK Nr 474/2008
- Status last verified
- Nov 2010
- First submitted
- 5 Dec 2008
- Last updated
- 22 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Humoral and Cellular Immunity of Low and High-responders After TBE Vaccination
- ClinicalTrials.gov ID
- NCT00804219
- Acronym / sponsor ID
- FSME low-responder 1.1
- Conditions
- Tick-borne Encephalitis
- Keywords
- low responsiveness after vaccination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Dec 2008 (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.
The phenomenon of no- and low-responsiveness has been described after applications of different vaccines (e.g. hepatitis B, TBE) and is concerning about 2-10% of the vaccinees.
The aim of this project is to investigate the humoral and cellular immune responses of low-responders after TBE vaccination in order to find parameters regarding immunoregulation against TBE. It is of interest if non-responsiveness is a general immunological deficit of a distinct patient group or if it is a antigen-specific phenomenon.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TBE low responder | Experimental | Biological: TBE vaccination and influenza vaccination |
| FSME responder | Experimental | Biological: TBE vaccination and influenza vaccination |
| hepatitis B non-responder | Experimental | Biological: TBE vaccination and influenza vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults (≥18 years) of both sexes without upper age limit
- Willingness to sign written informed consent form
- Basic vaccination plus one booster (minimum) of TBE-vaccine,
Key exclusion criteria (13 listed)
- Age: < 18 years
- Pregnancy or breast feeding
- Prior TBE infection
- Planned surgery within 2 weeks before/after any scheduled rabies vaccination during the entire study
- Concomitant medication: systemic cortisone, immune suppressive therapy 4 weeks before or planned medication during the study
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 |
|---|---|---|
| TBE vaccination and influenza vaccinationAlso: FSME-Immun ATC code: J07 BA1, Inflexal ATC code: J07 BB02FSME-Immun, 0,5 ml, i.m., 1x Inflexal 0,5 ml, i.m., 1x | Biological | FSME responder, TBE low responder, hepatitis B non-responder |
Primary outcome
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination
Time frame: 7 days after TBE-booster plus influenza vaccination
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 22 Jul 2011.
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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.
Ursula Wiedermann-Schmidt, MD, PhD principal investigator
Institute of Specific Prophylaxis and Tropical Medicine
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 TBE vaccination and influenza vaccination in people with Tick-borne Encephalitis, run by Medical University of Vienna at 1 site in Austria.
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 3 inclusion and 13 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 22 Jul 2011. 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 Austria. 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?
cellular TBE immunity (cytokine production) 7 days after TBE-booster plus influenza vaccination (time frame: 7 days after TBE-booster plus influenza vaccination). 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 22 Jul 2011.