Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057525
Status:
COMPLETED
Last Update Posted:
2011-06-30
First Post:
2003-04-03
Brief Title:
A New Anthrax Vaccine Administered by the Intramuscular IM Route in Healthy Adults
Sponsor:
DynPort Vaccine Company LLC A GDIT Company
Organization:
DynPort Vaccine Company LLC A GDIT Company
Study Overview
Official Title:
A Phase 1 Study of Safety and Immunogenicity of E Coli-Derived Recombinant Protective Antigen rPA a New Anthrax Vaccine Administered by the Intramuscular IM Route in Healthy Adults
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:
This study will provide preliminary safety and comparative immunogenicity data for the Ecoli derived rPA vaccine administered by intramuscular IM injection at Day 0 and Month 1Doses will range from 5 μg to 100 μg rPA and at each dose-level rPA will either be combined with phosphate-buffered saline PBS or adsorbed to Alhydrogel
Detailed Description:
This is a safety study with an open-label part 2 groups followed by a dose-ranging part evaluating safety and immunogenicity using a double-blind sequential-group design with randomization and placebo-control within each of the 6 groups Volunteers in each dose group will receive two IM injections at Day 0 and Month 1
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 |
|---|---|---|---|
| Anthrax | None | None | None |