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

Primary Purpose

Japanese Encephalitis Vaccine

Status

Unknown status

Phase

Phase 4

Locations

Austria

Study Type

Interventional

Intervention

IXIARO®- Japanese Encephalitis vaccine

About this trial

This is an interventional prevention trial for Japanese Encephalitis Vaccine focused on measuring Japanese Encephalitis vaccine, immune responses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Medical University of ViennaRecruiting
Medical University Vienna, Institute of Specific Prophylaxis and Tropical MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

young individuals

elderly individuals

Arm Description

Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

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.

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

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

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.

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

Full Information

NCT ID

NCT03971058

First Posted

May 29, 2019

Last Updated

May 29, 2019

Sponsor

Medical University of Vienna

Collaborators

Valneva Austria GmbH

1. Study Identification

Unique Protocol Identification Number

NCT03971058

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

Collaborators

Valneva Austria GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Japanese Encephalitis Vaccine

Keywords

Japanese Encephalitis vaccine, immune responses

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

young individuals

Arm Type

Active Comparator

Arm Description

Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Arm Title

elderly individuals

Arm Type

Active Comparator

Arm Description

Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Intervention Type

Biological

Intervention Name(s)

IXIARO®- Japanese Encephalitis vaccine

Intervention Description

Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine

Primary Outcome Measure Information:

Title

JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3

Description

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)

Time Frame

Visit 3 day 42+/-4

Secondary Outcome Measure Information:

Title

Testing the difference of the JEV antibody titer between young and elderly adults

Description

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

Time Frame

Visit 1, day 0) till Visit 4 (day 168 +/- 14)

Title

Testing cellular immunity

Description

Time Frame

Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2).

Title

Testing of lymphocyte populations with FACS analysis

Description

Testing of lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount

Time Frame

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

Title

Testing of CMV serology

Description

Testing of CMV Seropositivity at the time of the booster vaccination with IXIARO® at Visit 1 (day 0) in both age groups

Time Frame

Visit 1, day 0

Title

TBE titer increase/course

Description

Time Frame

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)

Title

Testing of cellular immunity-Testing of cytokine production

Description

Time Frame

Visit 1, day 0; Visit 2, day 7 (+2)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Studien Team

Phone

+43140160

Ext

38276

isptm-studien@meduniwien.ac.at

First Name & Middle Initial & Last Name or Official Title & Degree

Ines Zwazl, BA

Phone

+43140160

Ext

38276

ines.zwazl@meduniwien.ac.at

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ursula Wiedermann-Schmidt, Univ Prof MD

Organizational Affiliation

Medical University of Vienna, ISPTM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Studien Team

Phone

+43140160

Ext

38276

isptm-studien@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Ines Zwazl, BA

Phone

+43140160

Ext

38202

ines.zwazl@meduniwien.ac.at

Facility Name

Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ursula Wiedermann, MD, PhD

Phone

0043 1 40160

Ext

38260

ursula.wiedermann@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Ursula Wiedermann, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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