Japanese EncephalitisPhase 4NCT01954810
Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
A Phase 4 study testing Japanese encephalitis chimeric vaccine (JECV) in people with Japanese Encephalitis, run by Khon Kaen University at 1 site in Thailand.
Trial summary
This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago. Read more about this study
- Who is it for?
- Ages 72 to 80 monthsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- What is being tested?
- Japanese encephalitis chimeric vaccine (JECV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2013to May 2014
- 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 72 to 80 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up.
- Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
- Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
- In good general health, based on medical history and physical examination
Who cannot join
- Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05
- Planned participation in another clinical trial during the Day0-Day28 period
- Receipt of live vaccine within 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Chronic illness or any underlying illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pediatrics, Faculty of Medicine, Khon Kaen University
Muang, Changwat Khon Kaen, 40002
Surapon Wiangnon, M.D., +66-43-348382, suraponwiangnon@gmail.com
Pope Kosalaraksa, M.D.
About this study
Official title: Assessment of Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV
This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.
Read the detailed description
This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.
- Conditions
- Japanese Encephalitis
- Being tested
- Japanese encephalitis chimeric vaccine (JECV)
- Keywords
- JECV, IMOJEV, Booster response, Children, antibody response, Duration
- Medical subject headings
- Encephalitis, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Japanese encephalitis chimeric vaccine (JECV)Biological
Also called IMOJEV
Japanese encephalitis chimeric vaccine (JECV)will be administered to every children in the study for one dose and check for antibody response 4 weeks after vaccination
| Study group | Role | What they receive |
|---|---|---|
| Japanese encephaltis chimerix vaccine | No intervention | This is a single-arm study. Japanese encephalitis chimeric vaccine (JECV) will be administered to all subjects and check for antibody response 4 weeks after vaccination. Receives: Biological: Japanese encephalitis chimeric vaccine (JECV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibody titers after JECV vaccination
Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Japanese EncephalitisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pope Kosalaraksa, Khon Kaen University
- Investigators
- Pope Kosalaraksa, M.D., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954810
- Sponsor's protocol ID
- JEC24
- Status last verified
- Oct 2013
- First submitted
- 26 Sep 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children Previously Immunized With a Single Dose of JE-CV
- ClinicalTrials.gov ID
- NCT01954810
- Acronym / sponsor ID
- JEC24
- Conditions
- Japanese Encephalitis
- Keywords
- JECV, IMOJEV, Booster response, Children, antibody response, Duration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 7 Oct 2013 (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.
This study has aim to describe the immune response to the second dose of Japanese encephalitis chimeric vaccine (JECV) in children previously vaccinated with one dose of JECV 5 years ago.
Detailed description
This is a prospective study to demonstrate the boosting antibody response in children previously vaccinated with one dose of JECV 5 years ago.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Japanese encephaltis chimerix vaccine | No intervention | Biological: Japanese encephalitis chimeric vaccine (JECV)This is a single-arm study. Japanese encephalitis chimeric vaccine (JECV) will be administered to all subjects and check for antibody response 4 weeks after vaccination. |
Who may qualify
- Ages
- 72 to 80 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject who was vaccinated with 1 dose JE-CV in JEC02 and participated in 5 year follow-up in JEC05 trial and finished year 5 of follow-up.
- Provision of Informed Consent Form signed by at least one parent or other legally acceptable representative.
- Subject and parent/legally acceptable representative or guardian able to attend all scheduled visits and to comply with all trial procedures
- In good general health, based on medical history and physical examination
Key exclusion criteria (7 listed)
- Participation in another clinical trial investigating a vaccine which need to have vaccination or blood draw within the 4 weeks preceding the trial vaccination except JEC05
- Planned participation in another clinical trial during the Day0-Day28 period
- Receipt of live vaccine within 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine in the 4 weeks following the trial vaccination
- Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
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 |
|---|---|---|
| Japanese encephalitis chimeric vaccine (JECV)Also: IMOJEVJapanese encephalitis chimeric vaccine (JECV)will be administered to every children in the study for one dose and check for antibody response 4 weeks after vaccination | Biological | Japanese encephaltis chimerix vaccine |
Primary outcome
Neutralizing antibody titers after JECV vaccination
Time frame: 28 days
Neutralizing antibody titers before JECV booster (on D0), and after IMOJEV booster (on D28)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
Pope Kosalaraksa, M.D. principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Japanese encephalitis chimeric vaccine (JECV) in people with Japanese Encephalitis, run by Khon Kaen University at 1 site in Thailand.
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 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: status not confirmed, as of the sponsor's last update on 8 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 Pope Kosalaraksa, M.D. (+66-89-7112236, pkosalaraksa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutralizing antibody titers after JECV vaccination (time frame: 28 days). 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 8 Oct 2013.