Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00124865
Status:
WITHDRAWN
Last Update Posted:
2017-09-26
First Post:
2005-07-26
Brief Title:
Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine rFla-MBP Dose-Ranging Study
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Safety and Immunogenicity Evaluation of an Intranasal Recombinant Flagellin Subunit Campylobacter Vaccine rFla-MBP in Volunteers
Status:
WITHDRAWN
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open-labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses
Detailed Description:
This is an open labeled dose escalating trial in which a total of 32 subjects will receive one of four intranasal rFla-MBP vaccine doses according to the following chart
Group N rFla-MBP
A 8 25 micrograms
B 8 125 micrograms
C 8 625 micrograms
D 8 1000 micrograms
minimum of 6 volunteers per group
An interval no less than 60 days following the first dose will separate the first dose of each volunteer group receiving different rFla-MBP doses All volunteers will receive three immunizations The first dosing time point is Day 0 the second is Day 14 - 1 day the third is day 28 - 2 days Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose
Group N rFla-MBP
A 8 25 micrograms
B 8 125 micrograms
C 8 625 micrograms
D 8 1000 micrograms
minimum of 6 volunteers per group
An interval no less than 60 days following the first dose will separate the first dose of each volunteer group receiving different rFla-MBP doses All volunteers will receive three immunizations The first dosing time point is Day 0 the second is Day 14 - 1 day the third is day 28 - 2 days Blood and stool specimens will be collected at intervals to examine systemic and mucosal vaccine antigen-specific immune responses Vaccine safety will be actively monitored during vaccination and for 28 days following the third vaccine dose
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| rFla-MBP | OTHER | NMRC | None |
| WRAIR 949 | OTHER | None | None |
| HSRRB A-11697 | OTHER | None | None |