Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.

Phase 4

• Conditions: Japanese Encephalitis Vaccine
• Interventions: Biological: IXIARO®- Japanese Encephalitis vaccine

• Registration Number: NCT03971058
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

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.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.

Study Timeline

• Study Start: 2019-03-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-05-29
• Last Update Submitted: 2019-05-29
• Study First Posted: 2019-06-03
• Last Update Posted: 2019-06-03
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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

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Exclusion Criteria

• Already received an booster (3rd dose) of IXIARO ®
• Vaccination with other JE vaccine (e.g. Je-vax)
• clinically manifest infection with another Flavivirus within 1 year prior study inclusion (yellow fever, Dengue fever, West Nile, TBE)
• past infection with the JEV
• vaccination against yellow fever, Dengue, West Nile within 6 months prior to study inclusion
• TBE vaccination within the last 30 days prior to study inclusion
• immunosuppressive therapy (intake>14d) within 30 days before IXIARO booster till V3 (day 42+/-4), Corticosteroids like Prednisolon > and = 20mg/day; allowed: topic or inhalative application
• immunodeficiency or st. p. organ transplantation
• autoimmune disease except vitiligo or diseases of the thyroid gland with thyroid hormon substitution therapy
• immuntherapy within 2 weeks before or after Ixiaro Booster
• current acute infection or exacerbation of a chronic illness
• cancer within the last 5 years
• clinically significant haematological, renal, pulmonary, hepatic, neurological, cardiovascular disease which is not treated adequately within 12 weeks before Ixiaro booster
• known infection with HIV, Hep B and Hep C
• Guillain - Barré- Syndrome (GBS) - anamnestic
• anamnestic anaphylaxie, atopy oder severe hypersensivity against ingredients of IXIARO
• drug abuse/alcohol abuse
• pregnancy and breastfeeding
• plasma donation within the last 4 months
• receiving blood or immunglobulins within 3 months before v1
• significant mental disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
young individuals	IXIARO®- Japanese Encephalitis vaccine	Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
elderly individuals	IXIARO®- Japanese Encephalitis vaccine	Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Primary Outcome Measures

Name	Time	Method
JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3	Visit 3 day 42+/-4	Testing the difference of the JEV antibodies increase between young and elderly adults between Visit 1 (before booster vaccination) and Visit 3 (day 42+/-4 after Booster vaccination)

Secondary Outcome Measures

Name	Time	Method
Testing of lymphocyte populations with FACS analysis	Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2) and 42 days (Visit 3, day 42 (+/-4) after booster vaccination	Testing of lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount
Testing of cellular immunity-Testing of cytokine production	Visit 1, day 0; Visit 2, day 7 (+2)	Testing of cellular immunity (cytokine production of IL-2, TNF-alpha, IL-6, IL-10 after stimulation mit TBE Antigen) before and seven days after the booster vaccination with IXIARO® (Visit 1, day 0; Visit 2, day 7 (+2) in comparison between the age groups
Testing of CMV serology	Visit 1, day 0	Testing of CMV Seropositivity at the time of the booster vaccination with IXIARO® at Visit 1 (day 0) in both age groups
TBE titer increase/course	Visit 1, day 0), seven days (Visit 2, day 7 (+2), 42 days (Visit 3, day 42 (+/-4) und 6 Months (Visit 4, day 168 (+/- 14)	Tick borne encephalitis titer before booster vaccination with IXIARO® (Visit 1, day 0), seven days after the booster vaccination (Visit 2, day 7 (+2),and 42 days (Visit 3, day 42 (+/-4) after the booster vaccination and 6 months (Visit 4, day 168 (+/- 14) after the booster vaccination and the in comparison between age groups.
Testing the difference of the JEV antibody titer between young and elderly adults	Visit 1, day 0) till Visit 4 (day 168 +/- 14)	Testing the difference of the JEV antibody titer before the booster vaccination with IXIARO® (Visite 1, day 0) till Visit 4 (day 168 +/- 14) in comparison between the age groups
Testing cellular immunity	Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2).	Testing cellular immunity (cytokine production of IL-2, IFN-g, TNF-alpha, IL-6, IL-10, IL-21 after stimulation with JEV antigen) before the booster vaccination with IXIARO® (Visit 1, day 0), seven days (Visit 2, day 7 (+2) after and after 42 days (Visit 3, day 42 (+/-4)) after that in comparison between the age groups.

Trial Locations

Locations (2)

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine; 🇦🇹 Vienna, Austria

Medical University of Vienna; 🇦🇹 Vienna, Austria