Determining Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles Vaccine
Condition: Encephalitis, Japanese B
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine whether it is safe and effective to administer Japanese
      encephalitis (JE) live attenuated SA 14-14-2 vaccine at the same time as measles vaccine. If
      it is found to be safe, it will pave the way for use in routine vaccination programs. The
      hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles
      vaccine at the same time are protected against these diseases at the same level as those who
      receive the vaccines at different intervals.
    

Detailed description: 
      Japanese encephalitis is the leading cause of viral neurological disease and disability in
      Asia. The severity of sequelae, together with the volume of cases, make JE the most important
      cause of viral encephalitis in the world. Approximately 3 billion people-including 700
      million children-live in Asian areas at risk for JE. JE most commonly infects children
      between the ages of 1 and 15 years, and can also infect adults in areas where the virus is
      newly introduced. More than 50,000 cases are reported annually and cause an estimated 10,000
      to 15,000 deaths. This figure is believed to represent only a small proportion of the disease
      burden that actually exists.

      An effective vaccine has existed since 1941, but has not reached the poorest countries in
      Asia. During the 60 years that the vaccine has been available, JE has infected an estimated
      10.5 million children, resulting in more than 3 million deaths and more than 4 million
      children living with long-term disabilities. Control of this disease has been limited due to
      poor disease surveillance, a limited and unstable vaccine supply, lack of guidance and
      programmatic support for immunization, and limited advocacy.

      A successful vaccine should be safe, efficacious, affordable, administered in a single dose,
      and easily incorporated into the routine Expanded Programmes on Immunization (EPI) programs.
      This study will help ensure the safety of SA 14-14-2 simultaneously administered with measles
      vaccine, paving the way for its use in routine EPI programs. If this candidate becomes widely
      available, it will drastically increase the feasibility of routine JE immunization in Asia,
      reducing the devastating death and disability caused by this disease. In addition to
      impacting low-income countries, the vaccine will allow countries that purchase vaccine-such
      as Thailand, Vietnam, Sri Lanka, and India-to recover health care dollars, improve their
      present programs, and address other unmet health care needs.
    

Intervention name(s): Live Japanese encephalitis vaccine SA 14-14-2 (LJEV); Measles Vaccine (MV)
Intervention type(s): Biological; Biological
Intervention description(s): Live Japanese encephalitis vaccine SA 14-14-2 (LJEV) is lyophilized powder that looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid. Its container is a vial. It is stored and transported between 2°C to 8°C and protected from light. Each single human dose is 0.5 ml containing not less than 5.4 log particle flux unit (PFU) of live Japanese Encephalitis (JE) virus. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 200411129-3 manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China.; The Serum Institute of India (SII) measles vaccine provided routinely in the Expanded Program on Immunization (EPI) of the Philippines was the measles vaccine provided to the study participants. The vaccine met the requirements of the World Health Organization (WHO).
SII measles vaccine contained live attenuated (freeze-dried) Edmonston-Zagreb strain measles virus propagated on human diploid cells (HDC). Each single human dose when reconstituted in a volume of 0.5 ml contains no less than 1000 Cell culture infectious dose 50% (CCID50) of live virus particles. SII measles vaccine is presented as a yellowish-white dry cake. The vaccine should be reconstituted with the diluent supplied (sterile water for injection). A sterile disposable syringe and needle are supplied separately. The 0.5ml injection is delivered subcutaneously via auto-disable syringe. Lot number 2979.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Japanese Encephalitis; Japanese B Encephalitis; Japanese B Viral Encephalitis; Viral Encephalitis, Japanese B