Clinical Trial: Boosterability of Live Attenuated Japanese Encephalitis (JE) Vaccine in Children Who Have Previously Received Inactivated JE Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Assessment of the Immunogenicity and Safety of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine in Children in Sri Lanka

Brief Summary:

Japanese encephalitis virus 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 areas at risk in Asia 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 inactivated JE vaccine is currently being used in Sri Lanka. It is given to children in 3 doses, at 12 months of age, 13 months of age, and 2 years of age. A booster dose must also be given to children at 5 years of age. If Sri Lanka decides to replace the inactivated JE vaccine with the live attenuated JE vaccine, there will be many children who still need a 3rd or booster dose of the inactivated JE vaccine. This research study is being done to see if the live attenuated vaccine will work well to replace the inactivated JE vaccine and if it is safe in Sri Lankan children.


Detailed Summary:
Sponsor: PATH

Current Primary Outcome: The proportion of subjects with demonstrated seropositivity for JE at 28 days postimmunization with live attenuated JE vaccine

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Geometric mean titer (GMT) of serum antibody to JE among subjects at 28 days postimmunization with live attenuated JE vaccine
  • proportion of subjects with immediate reactions (within 30 minutes after injection, with emphasis on allergic reactions)
  • proportion of subjects with local and systemic reactions (including unsolicited events) measured during the first 7 days following vaccination
  • proportion of subjects with adverse events (AEs) (related or unrelated to vaccination) occurring from Day 8 to Day 28
  • serious adverse events (SAEs) (related or unrelated to vaccination) occurring from Day 0 to Day 365
  • the proportion of subjects with demonstrated seropositivity for JE at 365 days postimmunization with live attenuated JE vaccine
  • geometric mean titer (GMT) of serum antibody to JE among subjects at 365 days postimmunization with live attenuated JE vaccine


Original Secondary Outcome: Same as current

Information By: PATH

Dates:
Date Received: April 18, 2007
Date Started: July 2007
Date Completion:
Last Updated: May 4, 2009
Last Verified: April 2009