Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2025-12-25 @ 4:28 AM
NCT ID:
NCT01340820
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.
Study:
NCT01340820
Study Brief:
Protocol Section:
NCT01340820