Japanese EncephalitisNCT01163123
Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan
An observational study of Japanese Encephalitis, run by Mennonite Christian Hospital.
Trial summary
Japanese encephalitis (JE) is one of important zoonotic infectious diseases in Taiwan. JE caused by Japanese encephalitis virus (JEV) which transmitted by Culex tritaeniorhynchus and used swine as amplifying host. Infections leading to overt encephalitis are estimated to be 1 in 1000 cases. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Japanese Encephalitis
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Dec 2010
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers were recruited from 2 villages in Hualien county Taiwan. There were at least one patient who had confirmed diagnosis of Japanese virus encephalitis in past 2 years. Many pig farms were located in these 2 villages also. The volunteers are either living or working in the villages during 2010 summer. We had blood test for IgM, IgG for Japanese virus encephalitis before and after the summer season to identify possible subclinical infection. At the same time, mosquito were analyzed by RT-PCR periodically to identify possible virus in the community.
Who may be able to join
- Living in the specific 2 villages in Hualien county
- Aged 18-85
Who cannot join
- 1. Difficulty to have blood test due to coagulopathy or small blood vessels
About this study
Japanese encephalitis (JE) is one of important zoonotic infectious diseases in Taiwan. JE caused by Japanese encephalitis virus (JEV) which transmitted by Culex tritaeniorhynchus and used swine as amplifying host. Infections leading to overt encephalitis are estimated to be 1 in 1000 cases. Among JE confirmed cases, approximately 25 percent of cases die and 50 percent of the survivals develop permanent neurologic and/or psychiatric sequelae. JEV circulated in Taiwan are belonged to genotype III and the vaccine strain selected from same genotype. Genotype I JEV was first detected in northern Taiwan in 2008 by CDC, and the same genotype JEV were detected in mosquito collected in central Taiwan by our group. In order to study the genotypic shift of JEV in Taiwan areas, and the effects of the replacement of genotype on vaccine, we will conduct the JEV seroepidemiology in Hualien county which was the highest incidence of JEV in Taiwan. The aims of this study were: (1) study the circulating of genotype I JEV in Hualien county; (2) determine the virulence of genotype I JEV in human; (3) differential diagnosis of JEV genotype I or III infection among confirmed cases; (4) measure the cross neutralizing activity, after immunized with genotype III JEV vaccine, against genotype I JEV; (5) determine the age-specific seroprevalence of JEV antibody; (6) estimate the annual risk of infection for JEV.
Read the detailed description
According to CDC Taiwan epidemiology data, Hualien county had 6 confirmed JEV infection patients in 2009 witch was the highest county in Taiwan. Since mass vaccination was arranged since 45 years ago in Taiwan, most of the JEV infection was happened on the elderly, possible due to aging and immune compromised. However, from Mennonite Christian Hospital and CDC records, most of the confirmed JEV patients in Hualien county were aboriginal people. The youngest patient in 2009 is around 30-year-old who lived in the mountain side aboriginal village. Whether aboriginal people are at more risk for JEV infection or Genotype I JEV was appeared in Hualien with more virulent, resistent to vaccine protection is unknown.
In order to understand the risk of JEV infection and environmental (mosquito, swine) surveillance, we had arranged a small cohort study in 2 villages. The 2 villages are located at middle Hualien with direct distance around 20 KM between each other. Both villages had several pig farms and mosquito numbers in summer were very high. Both villages had document JEV infection resident in past 2 years. The first village was near the river ready to entrance the sea (wetlands) and many migrate birds appeared in the summer every year. The residence were mostly Han people. The seconds village was located very closed to the central mountain Taiwan and the residence were almost aboriginal people.
In this year 2010, we plan to do the following research:
- Collect mosquito in 2 villages since May.2010 with RT-PCT method to identify the JEV genotype
- Collect sera from swine in 2 villages to identify the JEV genotype
- Collect sera from 312 residency in 2 villages at May and Sep 2010 to detect sub-clinical infection rate. ( estimated sub-clinical infection rate = 2.5%)
- Identify the JEV from new diagnosed patient in 2010.
Since virus was hardly detected by RT-PCR or virus isolation from JEV infected patient, the virus identified from mosquito or swine in the nearby may show indirect evidence of the JEV genotype.
After comparing the 2 sera from the same person during the summer in these 2 villages, we can identify:
- The subclinical infection rate of the JEV (genotype I or III, depends on JEV isolated from mosquito)
- Whether aboriginal people near the central mountains are at more risk then people near the wetlands.
- Conditions
- Japanese Encephalitis
- Keywords
- Subclinical infection of Japanese encephalitis virus
- Medical subject headings
- Encephalitis, Japanese
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the subclinical infection rate in the cohort population during the summer ( May 2010 ~ Sep 2010)
We exam 2 sera from volunteer collected seperately on May and October 2010 to estimate the subclinical infection rate. Subclinical infection rate was defined by one of the following
- 4 times increased in IgG titer
- Appearance of IgM in the second sera
- Apperance of Anti-NS1 antibody in the second sera
Measured: May 2010 - Oct 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mennonite Christian Hospital
- Sponsor type
- University, hospital or other
- Investigators
- ChenChang Shih, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01163123
- Sponsor's protocol ID
- D9902
- Status last verified
- Jul 2010
- First submitted
- 14 Jul 2010
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan
- ClinicalTrials.gov ID
- NCT01163123
- Acronym / sponsor ID
- D9902
- Conditions
- Japanese Encephalitis
- Keywords
- Subclinical infection of Japanese encephalitis virus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Mennonite Christian HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 15 Jul 2010 (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.
Japanese encephalitis (JE) is one of important zoonotic infectious diseases in Taiwan. JE caused by Japanese encephalitis virus (JEV) which transmitted by Culex tritaeniorhynchus and used swine as amplifying host. Infections leading to overt encephalitis are estimated to be 1 in 1000 cases. Among JE confirmed cases, approximately 25 percent of cases die and 50 percent of the survivals develop permanent neurologic and/or psychiatric sequelae. JEV circulated in Taiwan are belonged to genotype III and the vaccine strain selected from same genotype. Genotype I JEV was first detected in northern Taiwan in 2008 by CDC, and the same genotype JEV were detected in mosquito collected in central Taiwan by our group. In order to study the genotypic shift of JEV in Taiwan areas, and the effects of the replacement of genotype on vaccine, we will conduct the JEV seroepidemiology in Hualien county which was the highest incidence of JEV in Taiwan. The aims of this study were: (1) study the circulating of genotype I JEV in Hualien county; (2) determine the virulence of genotype I JEV in human; (3) differential diagnosis of JEV genotype I or III infection among confirmed cases; (4) measure the cross neutralizing activity, after immunized with genotype III JEV vaccine, against genotype I JEV; (5) determine the age-specific seroprevalence of JEV antibody; (6) estimate the annual risk of infection for JEV.
Detailed description
According to CDC Taiwan epidemiology data, Hualien county had 6 confirmed JEV infection patients in 2009 witch was the highest county in Taiwan. Since mass vaccination was arranged since 45 years ago in Taiwan, most of the JEV infection was happened on the elderly, possible due to aging and immune compromised. However, from Mennonite Christian Hospital and CDC records, most of the confirmed JEV patients in Hualien county were aboriginal people. The youngest patient in 2009 is around 30-year-old who lived in the mountain side aboriginal village. Whether aboriginal people are at more risk for JEV infection or Genotype I JEV was appeared in Hualien with more virulent, resistent to vaccine protection is unknown.
In order to understand the risk of JEV infection and environmental (mosquito, swine) surveillance, we had arranged a small cohort study in 2 villages. The 2 villages are located at middle Hualien with direct distance around 20 KM between each other. Both villages had several pig farms and mosquito numbers in summer were very high. Both villages had document JEV infection resident in past 2 years. The first village was near the river ready to entrance the sea (wetlands) and many migrate birds appeared in the summer every year. The residence were mostly Han people. The seconds village was located very closed to the central mountain Taiwan and the residence were almost aboriginal people.
In this year 2010, we plan to do the following research:
- Collect mosquito in 2 villages since May.2010 with RT-PCT method to identify the JEV genotype
- Collect sera from swine in 2 villages to identify the JEV genotype
- Collect sera from 312 residency in 2 villages at May and Sep 2010 to detect sub-clinical infection rate. ( estimated sub-clinical infection rate = 2.5%)
- Identify the JEV from new diagnosed patient in 2010.
Since virus was hardly detected by RT-PCR or virus isolation from JEV infected patient, the virus identified from mosquito or swine in the nearby may show indirect evidence of the JEV genotype.
After comparing the 2 sera from the same person during the summer in these 2 villages, we can identify:
- The subclinical infection rate of the JEV (genotype I or III, depends on JEV isolated from mosquito)
- Whether aboriginal people near the central mountains are at more risk then people near the wetlands.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers were recruited from 2 villages in Hualien county Taiwan. There were at least one patient who had confirmed diagnosis of Japanese virus encephalitis in past 2 years. Many pig farms were located in these 2 villages also. The volunteers are either living or working in the villages during 2010 summer. We had blood test for IgM, IgG for Japanese virus encephalitis before and after the summer season to identify possible subclinical infection. At the same time, mosquito were analyzed by RT-PCR periodically to identify possible virus in the community.
Key inclusion criteria (2 listed)
- Living in the specific 2 villages in Hualien county
- Aged 18-85
Key exclusion criteria (1 listed)
- 1. Difficulty to have blood test due to coagulopathy or small blood vessels
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the subclinical infection rate in the cohort population during the summer ( May 2010 ~ Sep 2010)
Time frame: May 2010 - Oct 2010
We exam 2 sera from volunteer collected seperately on May and October 2010 to estimate the subclinical infection rate. Subclinical infection rate was defined by one of the following 1. 4 times increased in IgG titer 2. Appearance of IgM in the second sera 3. Apperance of Anti-NS1 antibody in the second sera
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2010.
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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.
ChenChang Shih study director
Questions about this trial
What is this clinical trial studying?
An observational study of Japanese Encephalitis, run by Mennonite Christian 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 2 inclusion and 1 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 16 Jul 2010. 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.
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?
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?
Measure the subclinical infection rate in the cohort population during the summer ( May 2010 ~ Sep 2010) (time frame: May 2010 - Oct 2010). 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 16 Jul 2010.