Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00442169
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 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.
Study:
NCT00442169
Study Brief:
Protocol Section:
NCT00442169