Tick Borne EncephalitisPhase 2immunisationNCT00890422
Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine
A Phase 2 study testing FSME vaccination (FSME-Immun) in people with Tick Borne Encephalitis, run by Elisabethinen Hospital at 2 sites in 2 countries.
Trial summary
The study aims to answer this question: whether adequate immunity can be achieved in a short time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation schedules? The investigators will test the immunogenicity (the degree of immunity achieved) of each of the immunisation schedules at… Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tick Borne Encephalitis
- What is being tested?
- FSME vaccination (FSME-Immun)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2007to Jul 2010
- Phase
- Phase 2
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent
- FSME antibody level < 7IU/ml (ELISA), retrospective
- FSME antibody (IgG) < 63 VIEU/ml (ELISA), retrospective
- FSME antibody (IgM) negative
- FSME antibody inhibition capacity <1:10-retrospective
- available for the next 56 days
Who cannot join
- age not 19 or over 65
- pregnancy
- risk of becoming pregnant
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine
The study aims to answer this question: whether adequate immunity can be achieved in a short time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation schedules? The investigators will test the immunogenicity (the degree of immunity achieved) of each of the immunisation schedules at various times after the injections. If the results of this clinical study are positive, it may then be possible to develop the most successful immunisation schedule so that it can be used routinely. This means that the results of the clinical study have an enormous practical value in preventing TBE in people travelling or moving into areas with a high TBE risk.
Read the detailed description
The data from at least 99 individuals will be needed if the study is to draw reliable conclusions. One-third of these individuals will receive 3 injections in all: 2 on the first day and the third injection 4 days later (immunisation schedule 1). Another one-third will receive 2 injections in all: one on the first day and one injection 4 days later (immunisation schedule 2). The remaining one-third will also receive 2 injections, both of these on the first day (immunisation schedule 3). Participants will be assigned completely randomly (by chance) to one of these three groups. So each participant stands a 33% chance (a 1:2 chance) of receiving any one particular immunisation schedule. If you agree to take part, the process will be as follows:
Brief Overview of the Course of the Clinical Study:
Vaccination scheme 1
Vaccination scheme 2
Vaccination scheme 3
Vaccinations:
I = Vaccination with FSME-IMMUN 0,5ml
- Scheme 1: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each, 1 vaccination at U2 (day 4), injection into the left upper arm
- Scheme 2: one vaccination at U1 (day 0) and at U2 (day 4), injections into the left upper arm each
- Scheme 3: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each
- Conditions
- Tick Borne Encephalitis
- Being tested
- FSME vaccination (FSME-Immun)
- Keywords
- encephalitis, FSME, central european encephalitis
- Medical subject headings
- Encephalitis, Tick-Borne, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSME vaccination (FSME-Immun)Biological
Also called FSME-Immun 0.5 ml
intra muscular 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| 1FSME vaccination | Experimental | 2 vaccination on day 0 Receives: Biological: FSME vaccination (FSME-Immun) |
| 2 FSME vaccination | Experimental | 1 vaccination on day 0 and one vaccination on day 4 Receives: Biological: FSME vaccination (FSME-Immun) |
| 3 FSME vaccination | Experimental | 2 vaccinations on day 0 and 1 vaccination on day 4 Receives: Biological: FSME vaccination (FSME-Immun) |
What is being measured
The primary outcome is the main question the study is designed to answer.
achievement of FSME-Antibody-level (IgG) >25IU/ml at visit U2, U3, U4, U5, U6, U7, U8 and U9-yes/no achievement of FSME antibody-level (IgG) of >126VIEU/ml at U2, U3;U4, U5, U6, U7, U8 and U9-yes/no
Measured: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
Secondary outcomes (1)
FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9
Measured: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMar 2007
- Primary completionNov 2009 (estimated)
- Study completionJul 2010 (estimated)
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.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elisabethinen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation, ASOKLIF
- Investigators
- Helmut Mittermayer, Principal investigator, Elisabethinen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890422
- Sponsor's protocol ID
- ASOKLIF 0608/MI
- Other IDs
- Eudract number: 2006-006955-10
- Acronym
- immunisation
- Status last verified
- Apr 2009
- First submitted
- 28 Apr 2009
- Last updated
- 29 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine
- ClinicalTrials.gov ID
- NCT00890422
- Acronym / sponsor ID
- immunisation / ASOKLIF 0608/MI
- Conditions
- Tick Borne Encephalitis
- Keywords
- encephalitis, FSME, central european encephalitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Elisabethinen HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation, ASOKLIF
- Study start
- Mar 2007
- Primary completion
- Nov 2009 (estimated)
- Study completion
- Jul 2010 (estimated)
- First posted
- 29 Apr 2009 (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 study aims to answer this question: whether adequate immunity can be achieved in a short time, that is, by a rapid immunisation process, using at least one of 3 new TBE immunisation schedules? The investigators will test the immunogenicity (the degree of immunity achieved) of each of the immunisation schedules at various times after the injections. If the results of this clinical study are positive, it may then be possible to develop the most successful immunisation schedule so that it can be used routinely. This means that the results of the clinical study have an enormous practical value in preventing TBE in people travelling or moving into areas with a high TBE risk.
Detailed description
The data from at least 99 individuals will be needed if the study is to draw reliable conclusions. One-third of these individuals will receive 3 injections in all: 2 on the first day and the third injection 4 days later (immunisation schedule 1). Another one-third will receive 2 injections in all: one on the first day and one injection 4 days later (immunisation schedule 2). The remaining one-third will also receive 2 injections, both of these on the first day (immunisation schedule 3). Participants will be assigned completely randomly (by chance) to one of these three groups. So each participant stands a 33% chance (a 1:2 chance) of receiving any one particular immunisation schedule. If you agree to take part, the process will be as follows:
Brief Overview of the Course of the Clinical Study:
Vaccination scheme 1
Vaccination scheme 2
Vaccination scheme 3
Vaccinations:
I = Vaccination with FSME-IMMUN 0,5ml
- Scheme 1: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each, 1 vaccination at U2 (day 4), injection into the left upper arm
- Scheme 2: one vaccination at U1 (day 0) and at U2 (day 4), injections into the left upper arm each
- Scheme 3: 2 vaccinations at U1 (day 0), one injection into the left and the right upper arm each
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1FSME vaccination | Experimental | Biological: FSME vaccination (FSME-Immun)2 vaccination on day 0 |
| 2 FSME vaccination | Experimental | Biological: FSME vaccination (FSME-Immun)1 vaccination on day 0 and one vaccination on day 4 |
| 3 FSME vaccination | Experimental | Biological: FSME vaccination (FSME-Immun)2 vaccinations on day 0 and 1 vaccination on day 4 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consent
- FSME antibody level < 7IU/ml (ELISA), retrospective
- FSME antibody (IgG) < 63 VIEU/ml (ELISA), retrospective
- FSME antibody (IgM) negative
- FSME antibody inhibition capacity <1:10-retrospective
Key exclusion criteria (3 listed)
- age not 19 or over 65
- pregnancy
- risk of becoming pregnant
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 |
|---|---|---|
| FSME vaccination (FSME-Immun)Also: FSME-Immun 0.5 mlintra muscular 0.5 ml | Biological | 1FSME vaccination, 2 FSME vaccination, 3 FSME vaccination |
Primary outcome
achievement of FSME-Antibody-level (IgG) >25IU/ml at visit U2, U3, U4, U5, U6, U7, U8 and U9-yes/no achievement of FSME antibody-level (IgG) of >126VIEU/ml at U2, U3;U4, U5, U6, U7, U8 and U9-yes/no
Time frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
1 secondary outcome
FSME antibody level at U2, U3, U4, U5, U6, U7, U8 and U9
Time frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2009.
- ethics committee of the Elisabethinen hospitalLink provided by the sponsor.
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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.
Helmut Mittermayer principal investigator
Elisabethinen Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FSME vaccination (FSME-Immun) in people with Tick Borne Encephalitis, run by Elisabethinen Hospital at 2 sites in 2 countries.
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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
achievement of FSME-Antibody-level (IgG) >25IU/ml at visit U2, U3, U4, U5, U6, U7, U8 and U9-yes/no achievement of FSME antibody-level (IgG) of >126VIEU/ml at U2, U3;U4, U5, U6, U7, U8 and U9-yes/no (time frame: U2 (=day4) U3 (=day7) U4 (=day10) U5 (=day 14) U6 (=day21) U7 (=day28) U8 (=day42) U9 (=day56)). 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 29 Apr 2009.