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

Japanese Encephalitis Vaccine Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03971058
• Other study ID #: IXIARO-booster senescence
• Secondary ID: 2016-002894-36
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2019
• Est. completion date: March 2021

Study information

• Verified date: May 2019
• Source: Medical University of Vienna
• Contact: Studien Team
• Phone: +43140160
• Email: isptm-studien[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Encephalitis
• Encephalitis, Japanese
• Japanese Encephalitis Vaccine

Intervention

Biological:
• IXIARO®- Japanese Encephalitis vaccine
Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Austria	Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	Valneva Austria GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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).
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)