Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children
Condition: Encephalitis, Japanese B
MeSH terms: Encephalitis, Japanese; Encephalitis
Intervention: JEVAC
Intervention description: Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 1 Year
Maximum age: 3 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: inactivated Japanese encephalitis vaccine; vero cell; children; immunogenicity; safety

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.