- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163123
Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Living in the specific 2 villages in Hualien county
- Aged 18-85
Exclusion Criteria:
1. Difficulty to have blood test due to coagulopathy or small blood vessels
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
May 2010 - Oct 2010
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: ChenChang Shih
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Encephalitis, Arbovirus
- Encephalitis, Viral
- Central Nervous System Viral Diseases
- Central Nervous System Infections
- Infectious Encephalitis
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Encephalitis, Japanese
- Encephalitis
- Infections
- Virus Diseases
Other Study ID Numbers
- D9902 (Other Identifier: CTEP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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