Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097396
Status:
COMPLETED
Last Update Posted:
2011-06-30
First Post:
2004-11-23
Brief Title:
Safety Tolerability Immunogenicity of the Recombinant Plague Vaccine rF1V
Sponsor:
DynPort Vaccine Company LLC A GDIT Company
Organization:
DynPort Vaccine Company LLC A GDIT Company
Study Overview
Official Title:
A Phase 1 Open-Label Dose-Escalating Study to Evaluate the Safety Tolerability and Immunogenicity of the Recombinant Plague Vaccine rF1V in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2011-06
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:
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular IM injection at four ascending dose-levels The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular IM dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine
Detailed Description:
The Phase 1 clinical trial is designed as an open-label single-center dose-escalation study to evaluate the safety tolerability and immunogenicity of a two-dose regimen of rF1V in healthy volunteers at four dose-levels 20 ug 40 ug 80 ug and 160 ug rF1V in four sequential cohorts The protocol was amended 26 January 2006 to recruit volunteers from Cohort 4 to participate in an Extension Cohort 4 Extension volunteers will receive a third vaccination at day E-0 Day E-0 -1 should not exceed Day 240 of the Phase 1 study
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