Japanese Encephalitis Clinical Trial
Official title:
Safety and Immunogenicity of an Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Vietnamese Children
A dose escalating study with 3 different dosing regimens of the studied vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess the safety and immunogenicity. Two hundred children are enrolled and randomly assigned into 4 groups (50 children/group), each of which receive 2 doses of study / control vaccine subcutaneously, at 10-12 days interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, solicited and unsolicited adverse events occurs from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and 20-22 days post 2nd dose).
Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989
with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese
Encephalitis outbreaks successfully during those years.
However, mouse brain-derived JE vaccine production requires companies to compliance various
requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE
vaccines with Cell culture-derived JE vaccines.
Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived
vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and
Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety
and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer
adults.
In this study, a dose escalating study with 3 different dosing regimens of the studied
vaccine (JECEVAX) and a licensed vaccine (JEVAX-VABIOTECH Vietnam) is conducted in
Vietnamese children, aged 9-24 months to assess the safety and immunogenicity. Two hundred
children are enrolled and randomly assigned into 4 groups (50 children/group), each of which
receive 2 doses of investigate vaccines or control vaccine subcutaneously, at 10-12 days
interval. Safety issues included immediate reaction at the site of injection and systemic
reaction within 30 min of administration, solicited and unsolicited adverse events occurs
from the first dose to 30 days after second dose; SAE (from start of first dose to 30 days
after second dose), blood cell count, urea, ALT, AST. Immunogenicity outcomes include
seroconversion of neutralizing antibodies (blood samples are taken prior to 1st dose and
20-22 days post 2nd dose).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
| 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 |
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 | |
| 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 |
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 | |
| 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 | |
| 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 | |
| Unknown status |
NCT01163123 -
Seroepidemiology of Japanese Encephalitis Virus Infection in Hualien, Taiwan
|
N/A |