NCT00981175

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

Randomised, Double-blind, Phase 2 Study of the Safety, Immunogenicity and Duration of Immunity of ChimeriVax™-JE, Live Attenuated Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 54 Years
• Healthy volunteers: Accepted

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.

Detailed description

Participants will receive ChimeriVax™-JE or diluent on Day 0 and diluent or ChimeriVax™-JE on Day 28. A subset of participants in each group will receive a booster dose of ChimeriVax™-JE at Month 6. Follow-up visits will occur at 12 and 24 months. Eligible participants will then enter the long-term immunogenicity follow-up period with visits at approximately 36, 48, and 60 months after Day 0. No safety data will be collected in the long-term immunogenicity follow-up period.

Conditions

• Encephalitis
• Japanese Encephalitis

Interventions

Type	Name	Description
BIOLOGICAL	Live attenuated Japanese encephalitis virus, then ChimeriVax diluent	ChimeriVax™-JE, 0.5 mL subcutaneous on Day 0; ChimeriVax diluent 0.5 mL subcutaneous on Day 28
BIOLOGICAL	ChimeriVax diluent, then Live attenuated Japanese encephalitis virus	ChimeriVax diluent, 0.5 mL subcutaneous on Day 0 and ChimeriVax™-JE, 0.5 mL subcutaneous on Day 28.

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-06-01
• Completion: 2008-02-01
• First posted: 2009-09-22
• Last updated: 2012-07-16
• Results posted: 2011-04-29

Locations

1 site across 1 country: Australia