Japanese Encephalitis Clinical Trial
Official title:
Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03282370 -
Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam
|
Phase 3 | |
Recruiting |
NCT05568953 -
An Experimental Medicine Decipher of a Minimum Correlate of Cellular Immunity
|
Phase 2 | |
Completed |
NCT00776230 -
Immunogenicity of a Commercial Batch of JEV IC51 up to 24 Months Post Filling
|
Phase 3 | |
Completed |
NCT00594958 -
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
Completed |
NCT00604708 -
Immunogenicity Study of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
Completed |
NCT00596271 -
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440
|
Phase 3 | |
Completed |
NCT00595790 -
Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
Not yet recruiting |
NCT01954810 -
Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in Children
|
Phase 4 | |
Completed |
NCT01246479 -
Long Term Immunity and Safety Following Vaccination With the JEV IC51 (IXIARO®, JESPECT®) in Pediatric Population In Non Endemic Countries. Uncontrolled, Ph3 FU-Study
|
Phase 3 | |
Completed |
NCT00595270 -
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
Completed |
NCT00596102 -
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
Completed |
NCT00605085 -
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
Completed |
NCT00314132 -
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
|
Phase 3 | |
Active, not recruiting |
NCT01981967 -
Post-licensure Safety Study of IMOJEV® in Thailand
|
Phase 4 | |
Completed |
NCT01466387 -
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With MenACWY in Adults
|
Phase 3 | |
Completed |
NCT00314145 -
A Safety and Efficacy Study of Two Japanese Encephalitis Vaccines ChimeriVax™-JE and JE-VAX
|
Phase 3 | |
Completed |
NCT00981630 -
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
|
Phase 2 | |
Completed |
NCT01567865 -
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
|
Phase 4 | |
Completed |
NCT01656200 -
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
|
Phase 4 | |
Completed |
NCT01856205 -
Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis
|
Phase 2 |