Japanese EncephalitisPhase 3NCT01386827
Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis
A Phase 3 study testing Mouse brain derived japanese encephalitis vaccine (MB-JEV), Primary and booster immunizations with MB-JEV and C) primary immunizations with Ixiaro in people with Japanese Encephalitis, run by Helsinki University Central Hospital.
Trial summary
The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro. 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
- What is being tested?
- Mouse brain derived japanese encephalitis vaccine (MB-JEV), Primary and booster immunizations with MB-JEV and C) primary immunizations with Ixiaro
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Apr 2011
- Phase
- Phase 3
- 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
- Male and female travellers ≥ 18 years of age.
- General good health.
- Written informed consent.
- Ability to attend all visits scheduled in this study.
- Travellers who have previously got a primary vaccination series of 2 or 3 doses of JE-MB and now receive a booster vaccination , either MB-JEV or IXIARO, at the travel clinic for their journey to Asia, OR
- Travellers with no previous vaccination against JE who are given the primary vaccination series with IXIARO at a travel clinic prior to their journey to Asia.
Who cannot join
- - < 18 years of age.
- Acute disease at the time of enrollment.
- Pregnancy or lactation.
- Known immunodeficiency or immune suppressive treatment.
- Any chronic illness that might interfere with the immune response; history of JE.
- Alcohol or drug abuse.
- Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).
About this study
Official title: Ability of the New Vero-cell-derived Inactivated Japanese Encephalitis Vaccine (IXIARO) to Elicit a Booster Response in Travellers Previously Vaccinated With Traditional Mouse-brain Derived Vaccine (JE-MB)
The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro.
Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune responses in four groups: A) primary immunization with BMJEV, B) primary and secondary immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of serum samples collected before and after vaccination.
- Conditions
- Japanese Encephalitis
- Being tested
- Mouse brain derived japanese encephalitis vaccine (MB-JEV), Primary and booster immunizations with MB-JEV, C) primary immunizations with Ixiaro, S) Ixiaro booster to MBJEV primed
- Keywords
- Ixiaro, japanese encephalitis vaccine, booster
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouse brain derived japanese encephalitis vaccine (MB-JEV)Biological
Also called Korean Green Cross
- 2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 immunization and one booster dose of Ixiaro 0.5 ml > 2 years later
Primary and booster immunizations with MB-JEVBiological
Also called Korean Green Cross
2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 as primary immunization and one booster dose of 0.5 ml > 2 years later
C) primary immunizations with IxiaroBiological
Also called Ixiaro
2 0.5 ml doses of Ixiaro 28 days apart
S) Ixiaro booster to MBJEV primedBiological
Also called Ixiaro
0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
| Study group | Role | What they receive |
|---|---|---|
| A) primary immunization with MB-JEV | Active comparator | Volunteers immunized with MB-JEV Receives: Biological: Mouse brain derived japanese encephalitis vaccine (MB-JEV) |
| Primary and booster MBJEV vaccinations | Active comparator | Booster immunization with MB-JEV of vaccinees primed with MB-JEV Receives: Biological: Primary and booster immunizations with MB-JEV |
| C) primary immunizations with Ixiaro | Active comparator | Primary immunization with Ixiaro 2 dose Receives: Biological: C) primary immunizations with Ixiaro |
| S) Ixiaro booster to MBJEV primed | Active comparator | Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV Receives: Biological: S) Ixiaro booster to MBJEV primed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titers 1 month after last vaccine dose
Determination of antibody titers 1 month after last vaccine dose
Measured: 1 month
Secondary outcomes (1)
Antibody titers two years after vaccination
Measurement of antibody titers two years after vaccination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJan 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Anu Kantele, Helsinki University Central Hospital
- Investigators
- Elina Erra, MD, Principal investigator, Haartman Institute, University of HelsinkiLars Lindqvist, MD PhD, Principal investigator, Department of infectious diseases Stockholm, SwedenEili Huhtamo, PhD, Principal investigator, Haartman Institute, University of HelsinkiOlli Vapalahti, MD PhD, Principal investigator, Haartman Institute, University of HelsinkiSari Pakkanen, MSc, Principal investigator, Haartman Institute, University of HelsinkiSirkka Vene, BMA, Principal investigator, Swedish Institute of Infectious Disease ControlJukka Riutta, MD, Principal investigator, Travel clinic, Postitalo, LääkärikeskusAnu Kantele, MD PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01386827
- Sponsor's protocol ID
- 382/E7/07
- Status last verified
- Oct 2011
- First submitted
- 30 Jun 2011
- Last updated
- 28 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Erra EO, Askling HH, Rombo L, Riutta J, Vene S, Yoksan S, Lindquist L, Pakkanen SH, Huhtamo E, Vapalahti O, Kantele A. A single dose of vero cell-derived Japanese encephalitis (JE) vaccine (Ixiaro) effectively boosts immunity in travelers primed with mouse brain-derived JE vaccines. Clin Infect Dis. 2012 Sep;55(6):825-34. doi: 10.1093/cid/cis542. Epub 2012 Jun 13.
PubMed 22696017
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of the New Vero-cell-derived Inactivated Japanese Encephalitis Vaccine (IXIARO) to Elicit a Booster Response in Travellers Previously Vaccinated With Traditional Mouse-brain Derived Vaccine (JE-MB)
- ClinicalTrials.gov ID
- NCT01386827
- Acronym / sponsor ID
- 382/E7/07
- Conditions
- Japanese Encephalitis
- Keywords
- Ixiaro, japanese encephalitis vaccine, booster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 1 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 old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro.
Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune responses in four groups: A) primary immunization with BMJEV, B) primary and secondary immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of serum samples collected before and after vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A) primary immunization with MB-JEV | Active comparator | Biological: Mouse brain derived japanese encephalitis vaccine (MB-JEV)Volunteers immunized with MB-JEV |
| Primary and booster MBJEV vaccinations | Active comparator | Biological: Primary and booster immunizations with MB-JEVBooster immunization with MB-JEV of vaccinees primed with MB-JEV |
| C) primary immunizations with Ixiaro | Active comparator | Biological: C) primary immunizations with IxiaroPrimary immunization with Ixiaro 2 dose |
| S) Ixiaro booster to MBJEV primed | Active comparator | Biological: S) Ixiaro booster to MBJEV primedActual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female travellers ≥ 18 years of age.
Key exclusion criteria (7 listed)
- - < 18 years of age.
- Acute disease at the time of enrollment.
- Pregnancy or lactation.
- Known immunodeficiency or immune suppressive treatment.
- Any chronic illness that might interfere with the immune response; history of JE.
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 |
|---|---|---|
| Mouse brain derived japanese encephalitis vaccine (MB-JEV)Also: Korean Green Crossa) 2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 immunization and one booster dose of Ixiaro 0.5 ml > 2 years later | Biological | A) primary immunization with MB-JEV |
| Primary and booster immunizations with MB-JEVAlso: Korean Green Cross2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 as primary immunization and one booster dose of 0.5 ml > 2 years later | Biological | Primary and booster MBJEV vaccinations |
| C) primary immunizations with IxiaroAlso: Ixiaro2 0.5 ml doses of Ixiaro 28 days apart | Biological | C) primary immunizations with Ixiaro |
| S) Ixiaro booster to MBJEV primedAlso: Ixiaro0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV | Biological | S) Ixiaro booster to MBJEV primed |
Primary outcome
Antibody titers 1 month after last vaccine dose
Time frame: 1 month
Determination of antibody titers 1 month after last vaccine dose
1 secondary outcome
Antibody titers two years after vaccination
Time frame: 2 years
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 28 Oct 2011.
- Derived from this study: PubMed 22696017Erra EO, Askling HH, Rombo L, Riutta J, Vene S, Yoksan S, Lindquist L, Pakkanen SH, Huhtamo E, Vapalahti O, Kantele A. A single dose of vero cell-derived Japanese encephalitis (JE) vaccine (Ixiaro) effectively boosts immunity in travelers primed with mouse brain-derived JE vaccines. Clin Infect Dis. 2012 Sep;55(6):825-34. doi: 10.1093/cid/cis542. Epub 2012 Jun 13.
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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.
Elina Erra, MD principal investigator
Haartman Institute, University of Helsinki
Lars Lindqvist, MD PhD principal investigator
Department of infectious diseases Stockholm, Sweden
Eili Huhtamo, PhD principal investigator
Haartman Institute, University of Helsinki
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mouse brain derived japanese encephalitis vaccine (MB-JEV), Primary and booster immunizations with MB-JEV and C) primary immunizations with Ixiaro in people with Japanese Encephalitis, run by Helsinki University Central Hospital.
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 6 inclusion and 7 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 28 Oct 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Antibody titers 1 month after last vaccine dose (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01386827, which also lists 1 linked publication.
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 28 Oct 2011.