Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT01340820
Status:
COMPLETED
Last Update Posted:
2012-08-16
First Post:
2011-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of AERAS 422 in Healthy Adults
Sponsor:
Aeras
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Controlled, Double-blind, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of AERAS-422 in Healthy Adults
Status:
COMPLETED
Status Verified Date:
2012-08
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 immunogenicity of AERAS-422 in healthy, BCG-naïve adults.
Detailed Description:
This is a Phase I, randomized, controlled, double-blind, dose-escalation study of AERAS-422. This study will be conducted in 24 HIV-negative, healthy adults who are BCG-naïve and negative for prior exposure to Mtb at enrollment. The study will be conducted at one or more clinical research sites in the United States.
AERAS-422 will be administered on Study Day 0 as a single 0.1 mL intradermal (ID) injection containing either \>= 10\^5 to \<10\^6 CFU (low-dose) or \>=10\^6 CFU (high-dose). BCG Tice® will be used as an active control for AERAS-422 and will be administered as a single 0.1 mL ID injection containing 1-8 x 10\^5 CFU on Study Day 0.
AERAS-422 will be administered on Study Day 0 as a single 0.1 mL intradermal (ID) injection containing either \>= 10\^5 to \<10\^6 CFU (low-dose) or \>=10\^6 CFU (high-dose). BCG Tice® will be used as an active control for AERAS-422 and will be administered as a single 0.1 mL ID injection containing 1-8 x 10\^5 CFU on Study Day 0.
Study Oversight
Has Oversight DMC:
True
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?: