This paper is published with the approval of the Director, KEMRI. This work was supported by funding from the Wellcome Trust to CJS (grant 083085) and DJN (grant 084633).
The funding agency had no role in the design of the study, data collection, analysis and interpretation. “
“Japanese encephalitis (JE) virus is an arbovirus that causes a devastating selleck inhibitor neurological disease resulting in high rates of mortality or neurologic sequelae. The severity of sequelae, together with the volume of cases, makes JE an important cause of encephalitis  and . 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 selleck 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 current study. This open label, non-randomized, single-arm trial was designed to evaluate the immunogenicity and safety of the co-administration of LJEV and measles vaccine among infants in order to facilitate introduction of LJEV into the Sri Lankan NIP at 9 months of age. The study was conducted from July 2007 to October 2008 secondly in three peri-urban health divisions of low JE endemicity in the District of Colombo. Healthy infants 9 months of age (plus or minus 2 weeks) who could be adequately followed for safety and who could attend all scheduled study visits were eligible. Infants with a history of measles or Japanese encephalitis (or major symptoms of either disease), or a history of previous receipt of any vaccine against these diseases, were excluded. Non-study vaccinations were restricted to between 2 weeks prior to enrollment until 28 days after study enrollment.