Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00082069
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2004-04-28
Brief Title:
Invaplex 50 Vaccine Dose-Ranging
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
Safety and Immunogenicity Study of an Intranasal Shigella Flexneri 2a Invaplex 50 Vaccine
Status:
COMPLETED
Status Verified Date:
2015-04
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 vaccine is given as a nose spray Volunteers will receive a 3-dose vaccination with doses spaced two weeks apart Volunteers will be assigned to a vaccination group based on their order of enrollment with consideration of their availability to complete the necessary vaccinations and follow-up visits
Detailed Description:
This is an open-labeled dose escalating trial in which a total of 32 subjects minimum of 24 allowable will receive one of four intranasal Invaplex 50 vaccine doses according to the following chart
Test articlesdose
Group N Invaplex 50
A 8 10 micrograms
B 8 50 micrograms
C 8 240 micrograms
D 8 480 micrograms
minimum of 6 volunteersgroup
An interval no less than 7 days following the third and final dose total of 35 days between initial dose at the lower dose level and the next initial dose at the next higher dose level will separate volunteer groups receiving different doses All volunteers will receive three immunizations The first dosing time point is Day 0 the second is Day 14 - one day and 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 vaccination dose
Test articlesdose
Group N Invaplex 50
A 8 10 micrograms
B 8 50 micrograms
C 8 240 micrograms
D 8 480 micrograms
minimum of 6 volunteersgroup
An interval no less than 7 days following the third and final dose total of 35 days between initial dose at the lower dose level and the next initial dose at the next higher dose level will separate volunteer groups receiving different doses All volunteers will receive three immunizations The first dosing time point is Day 0 the second is Day 14 - one day and 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 vaccination 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 |
|---|---|---|---|
| WRAIR 1085 | OTHER | None | None |
| HSRRB A-12528 | OTHER | USAMRMC | None |