Clinical Trial: Safety and Immunogenicity of ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Randomized, Double-blind, Placebo Controlled Phase II Trial of the Safety, Tolerability and Immunogenicity of Lyophilized ChimeriVax-WN02 West Nile Vaccine in Healthy Adults
Brief 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 Summary:
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.
Sponsor: Sanofi Pasteur, a Sanofi Company
Current Primary Outcome:
- Number of Participants With Fourfold or Greater Post-vaccination Titers (Seroconversion). [ Time Frame: Day 28 post-vaccination ]Seroconversion was defined as a fourfold or greater rise in titer between pre- and post-immunization samples
- Number of Viremic Participants Post-vaccination [ Time Frame: Day 21 post-vaccination ]Viremic = detectable level of ≥ 10 plaque-forming units (PFU)/mL
- Treatment-emergent Adverse Events Reported As Related to Study Treatment in at Least 5% of Participants in Any Active Treatment Group Post-vaccination. [ Time Frame: Days 0 to 28 post-vaccination ]
Original Primary Outcome:
Current Secondary Outcome: Geometric Mean Titers of Neutralizing Antibody Titers Pre- and Post-vaccination. [ Time Frame: Days 0, 14, and 28 post-vaccination ]
Original Secondary Outcome:
Information By: Sanofi
Dates:
Date Received: February 27, 2007
Date Started: December 2005
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016
