Safety and Immunogenicity of JECEVAX in Young Children
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      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).
    

Detailed description: 
      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).
    

Intervention name(s): JEVAX; JECEVAX-1; JECEVAX-0.8; JECEVAX-0.5
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval; JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days; JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days; JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
Other intervention name(s): JECEVAX-HI; JECVAX-MED; JECEVAX-LOW
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; JECEVAX; Vietnam