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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00332956
Brief Summary:
This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 540. Selection of dosage and schedule will be based on GMCs and seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400 healthy adult volunteers will be enrolled (100 per group) in this study.
Detailed Description:
Primary Objective: To select a dosage and schedule of rF1V vaccine for further study based on the immune response to F1 and V antigens up to Day 210.
Secondary Objectives: 1) To assess the safety of three injections of rF1V vaccine administered IM at two dosage levels.
2\) To assess the onset and duration of the humoral immune response to F1 and V antigens.
3\) To assess the humoral immune response to rF1V antigen. 4) To collect and store blood samples for future plague related research.
Exploratory Objectives:
To assess additional humoral immune responses to rF1V vaccine antigens.
Study:
NCT00332956
Study Brief:
Protocol Section:
NCT00332956