Humoral and Cellular Immune ResponsesPhase 4NCT01398540
Cellular and Humoral Immunity in Elderly After Immunization With a Japanese Encephalitis Vaccine
A Phase 4 study testing IXIARO in people with Humoral and Cellular Immune Responses, run by Medical University of Vienna.
Trial summary
The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Humoral and Cellular Immune Responses
- What is being tested?
- IXIARO
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Nov 2013
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults (18-40 years old)
- adults (≥60 years),
- both sexes
- willingness to sign written informed consent form
Who cannot join
- age below 18 years or between 41-59 years old
- status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection
- previous immunization against yellow fever, japanese encephalitis (dengue or WNV)
- current acute infection (body temperature above 37,9°C)
About this study
Official title: Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.
The aim of this project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.
- Conditions
- Humoral and Cellular Immune Responses
- Being tested
- IXIARO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IXIAROBiological
2 immunizations (0,5ml) with a 28 day interval
| Study group | Role | What they receive |
|---|---|---|
| elderly | Experimental | subjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO Receives: Biological: IXIARO |
| young | Experimental | subjects 18 to 40 years old, receiving 2 immunisations with IXIARO Receives: Biological: IXIARO |
What is being measured
The primary outcome is the main question the study is designed to answer.
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
Measured: 7 days after the 2 JE vaccinations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humoral and Cellular Immune ResponsesStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Univ. Prof. Dr. Ursula Wiedermann, Medical University of Vienna
- Investigators
- Ursula Wiedermann, MD, PhD, Principal investigator, Institute of Specific Prophylaxis and Tropical medicine, Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398540
- Sponsor's protocol ID
- IX-sensesc 1.2
- Status last verified
- Mar 2018
- First submitted
- 19 Jul 2011
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Cellular and Humoral Immunity in Elderly People After Immunization With a Purified, Inactivated Japanese Encephalitis Vaccine.
- ClinicalTrials.gov ID
- NCT01398540
- Acronym / sponsor ID
- IX-sensesc 1.2
- Conditions
- Humoral and Cellular Immune Responses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 20 Jul 2011 (estimated)
- 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 project is to investigate humoral and cellular immune responses before and after immunisation with the Japanese encephalitis vaccine IXIARO in subjects above 60 years of age and 18-40 years old subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| elderly | Experimental | Biological: IXIAROsubjects are at least 60 years old (with no upper age limit), receiving 2 immunisations with IXIARO |
| young | Experimental | Biological: IXIAROsubjects 18 to 40 years old, receiving 2 immunisations with IXIARO |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adults (18-40 years old)
- adults (≥60 years),
- both sexes
- willingness to sign written informed consent form
Key exclusion criteria (4 listed)
- age below 18 years or between 41-59 years old
- status post japanese encephalitis, tick born encephalitis (TBE), dengue, yellow fever or West Nile virus infection
- previous immunization against yellow fever, japanese encephalitis (dengue or WNV)
- current acute infection (body temperature above 37,9°C)
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 |
|---|---|---|
| IXIARO2 immunizations (0,5ml) with a 28 day interval | Biological | elderly, young |
Primary outcome
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination
Time frame: 7 days after the 2 JE vaccinations
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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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, MD, PhD principal investigator
Institute of Specific Prophylaxis and Tropical medicine, Vienna
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IXIARO in people with Humoral and Cellular Immune Responses, run by Medical University of Vienna.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cellular immunity (cytokine production upon stimulation with Japanese Encephalitis (JE) Virus Antigen) 7 days after the 2. JE-vaccination (time frame: 7 days after the 2 JE vaccinations). 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 29 Mar 2018.