Clinical Trial: Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 2 (a), Dose-Blinded, Block-Randomized, Dose and Schedule Selection Study to Evaluate the Immunogenicity and Safety of the Recombinant Plague Vaccine rF1V in Health
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 Summary:
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.
Sponsor: DynPort Vaccine Company LLC, A CSC Company
Current Primary Outcome: To select a final dosage and schedule of rF1V vaccine based on the immune response to F1 and V antigens up to Day 210 [ Time Frame: Day 210 Interim Analysis ]
Original Primary Outcome: To select a final dosage and schedule of rF1V vaccine based on the immune response to F1 and V antigens up to Day 270
Current Secondary Outcome:
- To access the safety of three injections of rF1V vaccine administered IM at two dosage levels. [ Time Frame: Day 210 Interim Analysis ]
- To access the onset and duration of the humoral immune response to F1 and V antigens [ Time Frame: Final Clinical Study Reort ]
- To assess the humoral immune response to rF1V antigen [ Time Frame: Final Clinical Study Report ]
- To collect and store blood samples for future plague related research. [ Time Frame: Through Study Day 540 ]
Original Secondary Outcome:
- To access the safety of three injections of rF1V vaccine administered IM at two dosage levels.
- To access the onset and duration of the humoral immune response to F1 and V antigens
- To assess the humoral immune response to rF1V antigen
- To collect and store blood samples for future plague related research.
Information By: DynPort Vaccine Company LLC, A CSC Company
Dates:
Date Received: June 1, 2006
Date Started: May 2006
Date Completion:
Last Updated: November 28, 2011
Last Verified: November 2011
