Evaluation of Immunogenicity of Different Tick Borne Encephalitis (TBE) Fast Protective Traveler Schemes With Inactivated TBE Whole Virus Vaccine (immunisation)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tick Borne Encephalitis |
Biological: FSME vaccination (FSME-Immun) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Clinical Study to Test the Immunogenicity of Variant Schedules for TBE Rapid Immunisation Using Inactivated TBE (FSME) Vaccine |
- 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) ] [ Designated as safety issue: Yes ]
- 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) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 99 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | July 2010 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1FSME vaccination
2 vaccination on day 0
|
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml
|
|
Experimental: 2 FSME vaccination
1 vaccination on day 0 and one vaccination on day 4
|
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml
|
|
Experimental: 3 FSME vaccination
2 vaccinations on day 0 and 1 vaccination on day 4
|
Biological: FSME vaccination (FSME-Immun)
intra muscular 0.5 ml
Other Name: FSME-Immun 0.5 ml
|
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
Eligibility| Ages Eligible for Study: | 19 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion Criteria:
- age not 19 or over 65
- pregnancy
- risk of becoming pregnant
Contacts and Locations| Austria | |
| Elisabethinen Hospital | |
| Linz, upper Austria, Austria, 4020 | |
| Czech Republic | |
| nemocnice ceske Budejovice | |
| Ceske Budejovice, Czech Republic, 37087 | |
| Principal Investigator: | Helmut Mittermayer | Elisabethinen Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | Helmut Mittermayer/Univ.Prof. Dr., Elisabethinen Hospital |
| ClinicalTrials.gov Identifier: | NCT00890422 History of Changes |
| Other Study ID Numbers: | ASOKLIF 0608/MI, Eudract number: 2006-006955-10 |
| Study First Received: | April 28, 2009 |
| Last Updated: | April 28, 2009 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by Elisabethinen Hospital:
|
encephalitis FSME central european encephalitis |
Additional relevant MeSH terms:
|
Encephalitis Encephalitis, Tick-Borne Central Nervous System Viral Diseases Virus Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections |
Encephalitis, Arbovirus Arbovirus Infections Tick-Borne Diseases Encephalitis, Viral RNA Virus Infections Flavivirus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 23, 2013