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Phase I Trial of DAR-901

NCT02063555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2016-08-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

DAR-901

BIOLOGICAL

BCG

BIOLOGICAL

Sterile saline

Sponsors & Collaborators

  • Aeras

    collaborator OTHER

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Charles F. von Reyn, MD · Dartmouth College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-03-31
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02063555 on ClinicalTrials.gov