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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
| 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 :
- 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 :
- 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
Eligibility Criteria
| 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
| Contact: Studien Team | +43140160 ext 38276 | isptm-studien@meduniwien.ac.at | |
| Contact: Ines Zwazl, BA | +43140160 ext 38276 | ines.zwazl@meduniwien.ac.at |
Locations
| 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
| 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 |
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)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| 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. |
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| 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 |
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| Condition ICMJE | Japanese Encephalitis Vaccine | ||||
| Intervention ICMJE | Biological: IXIARO®- Japanese Encephalitis vaccine
Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
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:
major Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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 ) |
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| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| 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 |
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| PRS Account | Medical University of Vienna | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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