Japanese Encephalitis VaccinePhase 4NCT03971058
Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
A Phase 4 study testing IXIARO®- Japanese Encephalitis vaccine in people with Japanese Encephalitis Vaccine, run by Medical University of Vienna at 2 sites in Austria.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis Vaccine
- What is being tested?
- IXIARO®- Japanese Encephalitis vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Mar 2019to Mar 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 25Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Studien Team, +43140160 ext. 38276, isptm-studien@meduniwien.ac.at
Ines Zwazl, BA, +43140160 ext. 38202, ines.zwazl@meduniwien.ac.at
- Recruiting
Medical University Vienna, Institute of Specific Prophylaxis and Tropical Medicine
Vienna, 1090
Ursula Wiedermann, MD, PhD, 0043 1 40160 ext. 38260, ursula.wiedermann@meduniwien.ac.at
Ursula Wiedermann, MD, PhD
About this study
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.
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.
Read the 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.
- Conditions
- Japanese Encephalitis Vaccine
- Being tested
- IXIARO®- Japanese Encephalitis vaccine
- Keywords
- Japanese Encephalitis vaccine, immune responses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXIARO®- Japanese Encephalitis vaccineBiological
Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
| Study group | Role | What they receive |
|---|---|---|
| young individuals | Active comparator | Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine Receives: Biological: IXIARO®- Japanese Encephalitis vaccine |
| elderly individuals | Active comparator | Immune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine Receives: Biological: IXIARO®- Japanese Encephalitis vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Visit 3 day 42+/-4
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Visit 1, day 0; Visit 2, day 7 (+2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Mar 2019
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese Encephalitis VaccineStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Valneva Austria GmbH
- Responsible party
- Principal investigator, Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna
- Investigators
- Ursula Wiedermann-Schmidt, Univ Prof MD, Principal investigator, Medical University of Vienna, ISPTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971058
- Sponsor's protocol ID
- IXIARO-booster senescence
- Other IDs
- 2016-002894-36, 2016
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03971058
- Acronym / sponsor ID
- IXIARO-booster senescence
- Conditions
- Japanese Encephalitis Vaccine
- Keywords
- Japanese Encephalitis vaccine, immune responses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Valneva Austria GmbH
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Immune Responses After a Booster Immunisation With IXIARO® in Elderly Compared to Young Individuals.
| Arm | Type | Receives |
|---|---|---|
| young individuals | Active comparator | Biological: IXIARO®- Japanese Encephalitis vaccineImmune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine |
| elderly individuals | Active comparator | Biological: IXIARO®- Japanese Encephalitis vaccineImmune Responses After a Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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
- Already received an booster (3rd dose) of IXIARO ®
- Vaccination with other JE vaccine (e.g. Je-vax)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IXIARO®- Japanese Encephalitis vaccineBooster Immunisation With IXIARO®- Japanese Encephalitis vaccine | Biological | elderly individuals, young individuals |
Primary outcome
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)
6 secondary outcomes
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 cellular immunity
Time frame: Visit 1, day 0), seven days after booster vaccination (Visit 2, day 7 (+2).
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 CMV serology
Time frame: Visit 1, day 0
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)
Testing of cellular immunity-Testing of cytokine production
Time frame: Visit 1, day 0; Visit 2, day 7 (+2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
Related trials for Japanese Encephalitis Vaccine
Active, not recruitingPhase 4
Immunogenicity, Safety, and Antibody Persistence of Different Immunization Strategies Against Japanese Encephalitis
Japanese Encephalitis Vaccine
RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
Dengue, Chikungunya
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ursula Wiedermann-Schmidt, Univ Prof MD principal investigator
Medical University of Vienna, ISPTM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IXIARO®- Japanese Encephalitis vaccine in people with Japanese Encephalitis Vaccine, run by Medical University of Vienna at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Studien Team (+43140160 ext. 38276, isptm-studien@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JEV antibody titer increase/course between visit 1 (before the booster vaccination) and Visit 3 (time frame: Visit 3 day 42+/-4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2019.