Safety and Efficacy Study of Intravenous Immunoglobulin to Treat Japanese Encephalitis
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
Summary
Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of
an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening
conscious level and seizures. Around a third will die from the infection and half of
survivors have serious long-term neurological disability. The majority of those affected are
children. There are many causes of viral encephalitis, however Japanese encephalitis virus is
the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia
and the geographical range is expanding. There is no specific treatment for Japanese
encephalitis virus, although several have been trialed. In this study we examined the effect
of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis
in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese
encephalitis virus and suppress damaging inflammation in the brain. It has previously been
used in individual cases but never examined in a randomized trial. There was recently a trial
of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the
Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is
safe in this context, and that this treatment may alter the way the immune system manages the
infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely
given to children with suspected JE, with no increased risk of serious adverse events
compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability
randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with
Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory
markers called cytokines and blood brain barrier markers, and the effect of IVIG on these
relationships.
Phase:
Phase 2
Details
Lead Sponsor:
University of Liverpool
Collaborators:
B.P. Koirala Institute of Health Sciences Kanti Children's Hospital