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

Characterisation of Cellular and Humoral Immune Responses Following the First Booster Immunisation With the Inactivated, Purified Japanese Encephalitis Vaccine IXIARO® in Elderly Compared to Young Individuals.

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.

Study Overview

• Status: Unknown
• Conditions: Japanese Encephalitis Vaccine
• Intervention / Treatment: Biological: IXIARO®- Japanese Encephalitis vaccine

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Studien Team; Phone Number: 38276 +43140160; Email: isptm-studien@meduniwien.ac.at
• Study Contact Backup: Name: Ines Zwazl, BA; Phone Number: 38276 +43140160; Email: ines.zwazl@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Studien Team; Phone Number: 38276 +43140160; Email: isptm-studien@meduniwien.ac.at
    • Contact: Ines Zwazl, BA; Phone Number: 38202 +43140160; Email: ines.zwazl@meduniwien.ac.at
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
    • Contact: Ursula Wiedermann, MD, PhD; Phone Number: 38260 0043 1 40160; Email: ursula.wiedermann@meduniwien.ac.at
    • Principal Investigator: Ursula Wiedermann, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

major 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: young individuals; Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine	Biological: IXIARO®- Japanese Encephalitis vaccine; Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
Active Comparator: elderly individuals; Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine	Biological: IXIARO®- Japanese Encephalitis vaccine; Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3	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)	Visit 3 day 42+/-4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testing the difference of the JEV antibody titer between young and elderly adults	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	Visit 1, day 0) till Visit 4 (day 168 +/- 14)
Testing cellular immunity	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.	Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2).
Testing of lymphocyte populations with FACS analysis	Testing of lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount	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 CMV serology	Testing of CMV Seropositivity at the time of the booster vaccination with IXIARO® at Visit 1 (day 0) in both age groups	Visit 1, day 0
TBE titer increase/course	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.	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)
Testing of cellular immunity-Testing of cytokine production	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	Visit 1, day 0; Visit 2, day 7 (+2)

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Valneva Austria GmbH
• Investigators: Principal Investigator: Ursula Wiedermann-Schmidt, Univ Prof MD, Medical University of Vienna, ISPTM

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 1, 2021

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: immune responses; Japanese Encephalitis vaccine
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Encephalitis, Arbovirus; Encephalitis, Viral; Central Nervous System Viral Diseases; Central Nervous System Infections; Infectious Encephalitis; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Encephalitis, Japanese; Encephalitis
• Other Study ID Numbers: IXIARO-booster senescence; 2016-002894-36 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No