Clinical trial NCT01408537: Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
Official title: Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Encephalitis, Japanese B
Keywords: inactivated Japanese encephalitis vaccine
vero cell
children
immunogenicity
safety
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2011-08-03
Enrollment: 152
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the total number of clinical cases is about 50,000. Of these cases, about 50% result in permanent neuropsychiatric sequelae. The disease occurs mostly among children aged \<10 years. There is no specific antiviral treatment for JE. Vaccination is the single most important control measure. This study aims to evaluate the immunogenicity and safety of inactivated Vero cell derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da Biotechnology Co., Ltd, China "JEVAC" in Thai children.

152 healthy Thai children aged between 1-3 years will be vaccinated with "JEVAC" in a dose of 0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at one year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13 months study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing P3 strain. Adverse events will be observed for 28 days after each vaccination. Serious adverse events will be observed throughout the study period.


Eligibility criteria: Inclusion Criteria:

1. Healthy Thai children aged 1- 3 years
2. No previous history of JE vaccination
3. Available for all visited schedule in the study period.
4. Written inform consent signed by a parent or guardian

Exclusion Criteria:

1. Known serious underlying diseases such as nervous system, heart, kidney and liver diseases.
2. Known hypersensitivity to JE vaccine composition such as human albumin, dextran 40, etc.
3. Previous history of JE disease.
4. Receive the blood component within the past 3 months,
5. Known history of immunocompromised conditions such as HIV/AIDS, malignancy.
6. Under treatment of immunosuppressive drugs such as systemic corticosteroid and anti-neoplastic drug.
7. Febrile illness (temperature ≥37.5°C) or acute illness/infection on the day of vaccination
8. Plan to leave the study area before the end of study period.
9. Participating in other clinical trials.

Primary outcomes:
measure: Seroconversion Rate After Primary Vaccination
timeFrame: 28 days after second dose of JEVAC
Secondary outcomes:
measure: Geometric Mean Titer of NT After Primary and Booster Vaccination
timeFrame: 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC
measure: Adverse Events of Vaccine
timeFrame: 7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively
measure: Neutralizing Antibody Persistence One Year After the Primary Vaccination
timeFrame: 1 year after primary vaccination
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Department Tropical Pediatrics
state: Bangkok
Study officials:
affiliation: Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
name: Pornthep Chanthavanich, MD
role: PRINCIPAL_INVESTIGATOR
References: