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出境医 / 临床实验 / Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.

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

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.

Condition or disease Intervention/treatment Phase
Japanese Encephalitis Vaccine Biological: IXIARO®- Japanese Encephalitis vaccine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  1. JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3 [ Time Frame: 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 :
  1. Testing the difference of the JEV antibody titer between young and elderly adults [ Time Frame: 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

  2. Testing cellular immunity [ Time Frame: 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.

  3. Testing of lymphocyte populations with FACS analysis [ 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 ]
    Testing of lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount

  4. Testing of CMV serology [ Time Frame: 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

  5. TBE titer increase/course [ 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) ]
    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.

  6. Testing of cellular immunity-Testing of cytokine production [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Contacts
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Contact: Studien Team +43140160 ext 38276 isptm-studien@meduniwien.ac.at
Contact: Ines Zwazl, BA +43140160 ext 38276 ines.zwazl@meduniwien.ac.at

Locations
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Austria
Medical University of Vienna Recruiting
Vienna, Austria, 1090
Contact: Studien Team    +43140160 ext 38276    isptm-studien@meduniwien.ac.at   
Contact: Ines Zwazl, BA    +43140160 ext 38202    ines.zwazl@meduniwien.ac.at   
Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine Recruiting
Vienna, Austria, 1090
Contact: Ursula Wiedermann, MD, PhD    0043 1 40160 ext 38260    ursula.wiedermann@meduniwien.ac.at   
Principal Investigator: Ursula Wiedermann, MD, PhD         
Sponsors and Collaborators
Medical University of Vienna
Valneva Austria GmbH
Investigators
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Principal Investigator: Ursula Wiedermann-Schmidt, Univ Prof MD Medical University of Vienna, ISPTM
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2019) 		JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3 [ Time Frame: 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2019)
  • Testing the difference of the JEV antibody titer between young and elderly adults [ Time Frame: 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 [ Time Frame: 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.
  • Testing of lymphocyte populations with FACS analysis [ 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 ]
    Testing of lymphocyte populations via testing surface markers of different B and T cell subsets with FACS and bloodcount
  • Testing of CMV serology [ Time Frame: 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 [ 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) ]
    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 [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
Official Title  ICMJE 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Japanese Encephalitis Vaccine
Intervention  ICMJE Biological: IXIARO®- Japanese Encephalitis vaccine
Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
Study Arms  ICMJE
  • Active Comparator: young individuals
    Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
    Intervention: Biological: IXIARO®- Japanese Encephalitis vaccine
  • Active Comparator: elderly individuals
    Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
    Intervention: Biological: IXIARO®- Japanese Encephalitis vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 29, 2019) 		64
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03971058
Other Study ID Numbers  ICMJE IXIARO-booster senescence
2016-002894-36 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna
Study Sponsor  ICMJE Medical University of Vienna
Collaborators  ICMJE Valneva Austria GmbH
Investigators  ICMJE
Principal Investigator: Ursula Wiedermann-Schmidt, Univ Prof MD Medical University of Vienna, ISPTM
PRS Account Medical University of Vienna
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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