NCT00746798

Safety and Immunogenicity Study of ChimeriVax West Nile Vaccine in Healthy Adults

Randomized, Modified, Double-blind, Placebo-controlled, Phase II, Dose-ranging Study of the Safety and Immunogenicity of Single Dose ChimeriVax-WN02 Vaccine in Healthy Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 479 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if ChimeriVax West Nile vaccine is safe and effective in preventing West Nile disease in adults over 50 years of age.

Detailed description

Currently, the only method of prevention of West Nile infection is control of the mosquito vectors associated or avoidance of mosquito bites, which has proven largely ineffective. Developing a safe, effective vaccine and making it widely available will enhance the prospects of prevention and control of this disease. In addition, natural infections with the YF virus and WN virus are more severe in the elderly. Therefore, a study among healthy older subjects or those with well controlled chronic diseases will provide data to determine a ChimeriVax-WN02 vaccine dose that is immunogenic and well tolerated.

Conditions

• West Nile Fever

Interventions

Type	Name	Description
BIOLOGICAL	ChimeriVax-WN02 vaccine	low dose, approximately 4 x 3log10, given one time subcutaneously
BIOLOGICAL	ChimeriVax-WN02 vaccine	medium dose, approximately 4 x 4log10, given one time
BIOLOGICAL	ChimeriVax-WN02 vaccine	high dose, approximately 4 x 5log10, given one time subcutaneously
BIOLOGICAL	Placebo	0.9%Normal Saline for Injection, given one time subcutaneously

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2008-09-04
• Last updated: 2015-04-03
• Results posted: 2011-11-02

Locations

15 sites across 1 country: United States