NCT00463684

Live Attenuated Japanese Encephalitis (JE) Vaccine Coadministered With Measles Vaccine in Infants 9 Months of Age

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 9 Months – 9 Months
• Healthy volunteers: Accepted

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.

Conditions

• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine	Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium.
BIOLOGICAL	Live, attenuated measles vaccine	Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium.

Timeline

• Start date: 2007-07-07
• Primary completion: 2007-11-07
• Completion: 2008-10-06
• First posted: 2007-04-20
• Last updated: 2019-02-08
• Results posted: 2019-02-08

Locations

3 sites across 1 country: Sri Lanka