NCT01163123

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
312

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 16, 2010

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

July 14, 2010

Last Update Submit

July 15, 2010

Conditions

Keywords

Subclinical infection of Japanese encephalitis virus

Outcome Measures

Primary Outcomes (1)

  • 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 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

    May 2010 - Oct 2010

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \. Difficulty to have blood test due to coagulopathy or small blood vessels

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Encephalitis, Japanese

Condition Hierarchy (Ancestors)

Encephalitis, ArbovirusEncephalitis, ViralCentral Nervous System Viral DiseasesCentral Nervous System InfectionsInfectionsInfectious EncephalitisArbovirus InfectionsVector Borne DiseasesMosquito-Borne DiseasesVirus DiseasesRNA Virus InfectionsFlavivirus InfectionsFlaviviridae InfectionsEncephalitisBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Officials

  • ChenChang Shih

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 15, 2010

Study Start

May 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 16, 2010

Record last verified: 2010-07