Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Mennonite Christian Hospital
ClinicalTrials.gov Identifier:
NCT01163123
First received: July 14, 2010
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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.


Condition
Japanese Encephalitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan

Resource links provided by NLM:


Further study details as provided by Mennonite Christian Hospital:

Primary Outcome Measures:
  • Measure the subclinical infection rate in the cohort population during the summer ( May 2010 ~ Sep 2010) [ Time Frame: May 2010 - Oct 2010 ] [ Designated as safety issue: Yes ]

    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


Biospecimen Retention:   Samples Without DNA

The sera from volunteer was collected to detect IgG, IgM and anti-NS1 antibody against Japanese encephalitis virus


Estimated Enrollment: 312
Study Start Date: May 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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:

  1. Collect mosquito in 2 villages since May.2010 with RT-PCT method to identify the JEV genotype
  2. Collect sera from swine in 2 villages to identify the JEV genotype
  3. 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%)
  4. 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:

  1. The subclinical infection rate of the JEV (genotype I or III, depends on JEV isolated from mosquito)
  2. Whether aboriginal people near the central mountains are at more risk then people near the wetlands.
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  1. Living in the specific 2 villages in Hualien county
  2. Aged 18-85

Exclusion Criteria:

1. Difficulty to have blood test due to coagulopathy or small blood vessels

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01163123

Sponsors and Collaborators
Mennonite Christian Hospital
Investigators
Study Director: ChenChang Shih
  More Information

No publications provided

Responsible Party: Sheng-Hsuan Chen, Mennonite Christian Hospital
ClinicalTrials.gov Identifier: NCT01163123     History of Changes
Other Study ID Numbers: D9902
Study First Received: July 14, 2010
Last Updated: July 15, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Mennonite Christian Hospital:
Subclinical infection of Japanese encephalitis virus

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Encephalitis, Arbovirus
Encephalitis, Viral
Infection
Virus Diseases
Central Nervous System Viral Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Infections
Arbovirus Infections
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on October 19, 2014