Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332956
Status:
COMPLETED
Last Update Posted:
2011-12-02
First Post:
2006-06-01
Brief Title:
Title Recombinant Plague Vaccine rF1V in Healthy Volunteers
Sponsor:
DynPort Vaccine Company LLC A GDIT Company
Organization:
DynPort Vaccine Company LLC A GDIT Company
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 2a 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 safetyreactogenicity 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:
None
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?:
None