Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT00332956
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2006-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers
Sponsor:
DynPort Vaccine Company LLC, A GDIT Company
Organization:
Study Overview
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 Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: