Japanese Encephalitis Clinical Trial
Official title:
Assessment of the Immunogenicity and Safety of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine in Children in Sri Lanka
To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV) into the National Immunization Programme of Sri Lanka, we evaluated the safety and immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. The primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater than 80% for JE and greater than 90% for measles.
JE virus is an arbovirus that causes a devastating neurological disease resulting in high rates of mortality orneurologic sequelae. The severity of sequelae, together with the volume of cases, makes JE an important cause of encephalitis. The disease is endemic across temperate and tropical zones of Asia,and because of its zoonotic cycle, eradicating JE from the environment is unrealistic. Universal childhood vaccination is essential for disease control. In Sri Lanka, immunization against JE began in 1988. By 2006, two types of JE vaccines were available for use in Sri Lanka—inactivated mouse brain-derived vaccine and live attenuated SA-14-14-2 JE vaccine (LJEV). Only the inactivated vaccine was being used in the country's public-sector immunization program. Concern in Japan over a rare but potentially dangerous adverse event associated with a mouse brain-derived vaccine led the manufacturer in Japan to discontinue production in 2005, thus limiting global supply of inactivated JE vaccines and raising costs for remaining inactivated vaccines. In August of 2006, the World Health Organization stated in its position paper on Japanese encephalitis vaccines that the mouse brain-derived vaccine should be replaced by a new generation of JE vaccines. For Sri Lanka, switching to the less expensive LJEV was estimated in 2006 to save the National Immunization Programme (NIP) between US$8.6 and $8.9 million annually in direct vaccine costs alone. To generate local immunogenicity and safety data to guide policy for potential use of LJEV in Sri Lanka's NIP, the Ministry of Healthcare and Nutrition, in cooperation with PATH, initiated the study. The study was conducted in three peri-urban health divisions of low JE endemicity in the District of Colombo. ;
| 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 |
NCT00595790 -
Rapid Immunization 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 |
NCT00604708 -
Immunogenicity 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 |
NCT00596102 -
Longterm Immunogenicity of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Completed |
NCT00595270 -
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
|
Phase 3 | |
| Completed |
NCT00314132 -
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
|
Phase 3 | |
| Completed |
NCT00605085 -
Safety and Tolerability of the Japanese Encephalitis Vaccine IC51
|
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 |
NCT01656200 -
A Prospective, Open Label Study of Human T Cell Responses to Live Attenuated Japanese Encephalitis Vaccine SA14-14-2
|
Phase 4 | |
| Completed |
NCT01567865 -
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
|
Phase 4 | |
| Unknown status |
NCT01163123 -
Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan
|
N/A |