Thick-Borne Encephalitis
Conditions
Interventions
Trade Name: FSME Immun
Pharmaceutical Form: Solution for injection
Sponsors
Institute of Tropical Medicine Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 to =60 years of age at time of inclusion 2. Willingness to provide written informed consent 3. Personnel members at the Belgian Defense 4. Prepared to follow the study schedule Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Seropositive for TBE (tested during screening visit). 2. Subjects with a known allergy to one of the components of the vaccine 3. Immune depressed subjects or subjects who take immunodepressant and/or –stimulant medication 4. Planned land deployment to TBE endemic regions during the study period 5. Ongoing pregnancy or active child wish (for female subjects) 6. Planned vaccination with an inactivated vaccine within 2 weeks before or after each vaccination or with a live attenuated vaccines within 1 month before or after each vaccination 7. Yellow fever vaccination planned within the whole study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the time to seroconversion of the different schedules of accelerated TBE vaccination based on reactogenicity data up to 28 days after the first dose.;Secondary Objective: 1. To estimate the proportion of subjects with neutralizing antibodies (= 10) at day 7, day 14, day 21, day 28, month 3 and month 6 after the start of primary vaccination for the 5 different vaccination regimens. 2. To estimate the proportion of subjects with neutralizing antibodies (= 10) after completion of the primary vaccination schedule (1 year after the first dose)) for the 5 different vaccination regimens. 3. Occurrence of solicited local and general symptoms within 7 days after each vaccination. 4. Occurrence of AEs for 7 days after each vaccination. 5. Occurrence of SAEs for 14 days after each vaccination.;Primary end point(s): Seroconversion is defined as neutralizing antibodies = 10 based on the plaque reduction neutralization test (PRNT).;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Neutralizing antibodies as measured with PRNT. 2. Occurrence of solicited local and general symptoms, AEs and SAEs;Timepoint(s) of evaluation of this end point: Day 7, day 14, day 21, day 28, month 3, month 6 and year 1 | — |
Countries
Belgium
Contacts
Public ContactYven Van Herrewege
ITM Clinical Trial Unit
Outcome results
None listed