A Study of ChimeriVax™-JE Live Attenuated Vaccine in Healthy Adults

Summary

The purpose of this study is to assess the safety, tolerability, immunogenicity, and duration of immunity of one or two doses of ChimeriVax™-JE vaccine separated by 5 or 6 months in adults. Objectives: Safety: * Obtain safety and tolerability data of a single, fixed dose of ChimeriVax™-JE compared with a placebo in adult volunteers (≥ 18 to \<55 years) without prior Japanese encephalitis (JE) vaccination. Immunogenicity: * Obtain data on the antibody response in adult volunteers following administration of ChimeriVax™-JE * Assess the durability of the immune response in adult volunteers over 60 months following one or two doses of ChimeriVax™-JE.

Timeline

Start

2003-04

Primary completion

2004-06

Completion

2008-02

Publications

• Results Nasveld PE, Ebringer A, Elmes N, Bennett S, Yoksan S, Aaskov J, McCarthy K, Kanesa-thasan N, Meric C, Reid M. Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: randomized, double-blind, 5-year phase II study in healthy adults. Hum Vaccin. 2010 Dec;6(12):1038-46. doi: 10.4161/hv.6.12.13057. Epub 2010 Dec 1.

Drugs

Indications