Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      To facilitate introduction of live attenuated SA 14-14-2 Japanese encephalitis vaccine (LJEV)
      into the National Immunization Programme of Sri Lanka, we evaluated the safety and
      immunogenicity of co-administration of LJEV and measles vaccine at 9 months of age. The
      primary hypothesis was that the seropositivity rate at 28 days post vaccination in Japanese
      Encephalitis (JE) and measles concomitantly vaccinated subjects 9 months of age is greater
      than 80% for JE and greater than 90% for measles.
    

Detailed description: 
      JE virus is an arbovirus that causes a devastating neurological disease resulting in high
      rates of mortality orneurologic sequelae. The severity of sequelae, together with the volume
      of cases, makes JE an important cause of encephalitis. The disease is endemic across
      temperate and tropical zones of Asia,and because of its zoonotic cycle, eradicating JE from
      the environment is unrealistic. Universal childhood vaccination is essential for disease
      control. In Sri Lanka, immunization against JE began in 1988. By 2006, two types of JE
      vaccines were available for use in Sri Lanka-inactivated mouse brain-derived vaccine and live
      attenuated SA-14-14-2 JE vaccine (LJEV). Only the inactivated vaccine was being used in the
      country's public-sector immunization program. Concern in Japan over a rare but potentially
      dangerous adverse event associated with a mouse brain-derived vaccine led the manufacturer in
      Japan to discontinue production in 2005, thus limiting global supply of inactivated JE
      vaccines and raising costs for remaining inactivated vaccines. In August of 2006, the World
      Health Organization stated in its position paper on Japanese encephalitis vaccines that the
      mouse brain-derived vaccine should be replaced by a new generation of JE vaccines. For Sri
      Lanka, switching to the less expensive LJEV was estimated in 2006 to save the National
      Immunization Programme (NIP) between US$8.6 and $8.9 million annually in direct vaccine costs
      alone. To generate local immunogenicity and safety data to guide policy for potential use of
      LJEV in Sri Lanka's NIP, the Ministry of Healthcare and Nutrition, in cooperation with PATH,
      initiated the study. The study was conducted in three peri-urban health divisions of low JE
      endemicity in the District of Colombo.
    

Intervention name(s): Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine; Live, attenuated measles vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.; Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention