NCT00442169

Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

Randomized, Double-blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether a single subcutaneous injection of ChimeriVax-WN02 vaccine is well tolerated, safe and induces protective antibodies against West Nile Disease. The study is divided into two parts; in the first part, a comparison of 3 dose levels of the vaccine will be made, with an inactive control. In the second part, the optimum dose level chosen after the first part will be given to older volunteers.

Detailed description

West Nile Disease has been carried across the United States by migrating birds since it was first identified in New York city in 1999. It is transmitted by mosquitoes from birds to humans and can cause severe disease in some individuals. There is no specific treatment for West Nile Disease. The target population for a West Nile vaccine is older people, as they are more susceptible to severe disease. This trial includes a dose-finding part with a placebo control in young healthy adults, followed by a placebo-controlled examination of the chosen dose in older healthy adults. Outcome measures include a comparison of adverse events between active treatment and placebo, a comparison of antibody and viremia measurements between dose levels and across age groups for the dose chosen for Part 2.

Conditions

• West Nile Fever

Interventions

Type	Name	Description
BIOLOGICAL	ChimeriVax-WN02 Low Dose	Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region.
BIOLOGICAL	ChimeriVax-WN02 Medium Dose	Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
BIOLOGICAL	ChimeriVax-WN02 High Dose	Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
BIOLOGICAL	0.9% Saline solution	Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
BIOLOGICAL	ChimeriVax-WN02 High Dose	Single dose formulation given in a volume of 0.5 mL by subcutaneous injection to the deltoid region
BIOLOGICAL	0.9 % NaCl solution	Single dose given in a volume of 0.5 mL by subcutaneous injection to the deltoid region

Timeline

• Start date: 2005-12-01
• Primary completion: 2008-06-01
• Completion: 2009-04-01
• First posted: 2007-03-01
• Last updated: 2016-04-14
• Results posted: 2011-02-14

Locations

5 sites across 1 country: United States