The condition under investigation is the naturally aging immune system. The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis vaccine in elderly subjects (above 60 years of age) in comparison to a young study group.
Conditions
Interventions
Trade Name: IXIARO
Pharmaceutical Form: Injection
INN or Proposed INN: Japanese Encephalitis vaccine
Other descriptive name: JAPANESE ENCEPHALITIS VIRUS STRAIN SA14-14-2 (INACTIVATED) PRODUCED IN VERO
Sponsors
Medical University of Vienna (MUW)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - participation in the preceeding study "IXIARO®-senescence" (EudraCTno: 2010-018630-52) without protocoll violation OR 2 documented IXIARO® vaccinations 28 days (-8/+ 30 days) apart between January 2010 and April 2014 at the age of 18 to 40 years or above the age of 60. - good state of health including individuals with medically controlled minor underlying disease (such as hypertension, hypercholesterinemia, NIDDM) - willingness to sign written informed consent 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: - Already received an booster (3rd dose) of IXIARO ® - past infection with the JEV - yellow fever vaccination within the last 6 months - TBE vaccination within the last 30 days - current acute infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Testing the difference of the JEV-antibody titre increase between young and elderly adults between visit 1 (before booster vaccination) and visit 3 (6 weeks after booster vaccination).;Secondary Objective: Testing the difference of the JEV-antibody titre increase between young and elderly adults between visit 1 (before booster vaccination) and up to visit 4 (6 months after booster vaccination). Testing cellular immunity (cytokine production after JEV as well as TBE stimulation) on visit 1, 2 (one week after booster immunisation) and 3 between both age groups. Testing of surface markers of different T and B cell subsets before and after JE-booster vaccination (on visit 1-3) in comparison between both age groups. Testing TBE-antibody titres before and after JE-booster vaccination (on visit 1-4) in both age groups. Testing CMV serology at visit 1 in both age groups. ;Primary end point(s): Fold-increase of JEV-antibody titre between visit 1 (prior booster vaccination) to visit 3 ( 6 weeks after booster vaccination);Timepoint(s) of evaluation of this end point: visit 1 (prior booster vaccination) and visit 3 (6 weeks after booster vaccination) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): JEV-antibody titre before booster vaccination with IXIARO® (visit 1) as well as 7 days (visit 2) and 6 months (visit 4) after booster vaccination. Cellular immunity (cytokine production after JEV as well as TBE stimulation) before booster vaccination with IXIARO® (visit 1) as well as 7 days (visit 2) and 6 weeks (visit 3) after booster vaccination. Determination of surface markers of different T and B cell subsets before booster vaccination with IXIARO® (visit 1) as well as 7 days (visit 2) and 6 weeks (visit 3) after booster vaccination. Testing TBE-antibody titers before and after JE-booster vaccination (on visit 1-4). Correlation of CMV serology (visit 1) with humoral and cellular responses. ;Timepoint(s) of evaluation of this end point: visit 1 (prior booster vaccination) visit 2 (7 days after booster vaccination) visit 3 (6 weeks after booster vaccination) visit 4 (6 months after booster vacciantion) | — |
Countries
Austria
Contacts
Public ContactProf. Ursula Wiedermann-Schmidt
Institute of Specific Prophylaxis and Tropical Medicine (ISPTM)
Outcome results
None listed