NCT02063555

Phase I Trial of DAR-901

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple-Dose, Dose-Ranging Study of the Safety and Immunogenicity of DAR-901, a Killed, Non-Tuberculous Mycobacterial Vaccine, in HIV-negative and HIV-positive Adults Who Have Previously Received BCG

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, randomized, controlled, double-blind, multiple-dose, dose-ranging study of DAR 901, (an inactivated whole cell mycobacterial vaccine) to be conducted in HIV negative and HIV positive adults previously vaccinated with BCG. The goals of the trial are to determine the safety, tolerability, and immunogenicity of multiple doses of the vaccine at different dose levels, ranging from 0.1 to 1 mg.

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	DAR-901
BIOLOGICAL	BCG
BIOLOGICAL	Sterile saline

Timeline

• Start date: 2014-02-01
• Primary completion: 2016-03-01
• Completion: 2016-06-01
• First posted: 2014-02-14
• Last updated: 2016-08-02

Locations

1 site across 1 country: United States