NCT01340820

Study of AERAS 422 in Healthy Adults

A Phase 1, Randomized, Controlled, Double-blind, Dose-Escalation Study to Evaluate the Safety and Immunogenicity of AERAS-422 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
DRUG	AERAS-422	rBCG
DRUG	BCG Tice	1-8 x 10\^5 CFU

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-02-01
• Completion: 2012-05-01
• First posted: 2011-04-25
• Last updated: 2012-08-16

Locations

1 site across 1 country: United States