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Phase 1 ID93 + GLA-SE Vaccine Trial in Healthy Adult Volunteers

NCT01599897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-09-15

No results posted yet for this study

Summary

The purpose of this study is to determine the safety, tolerability, and immunogenicity in healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis. The vaccine, identified as ID93 + GLA-SE, consists of the recombinant four-antigen Mycobacterium tuberculosis recombinant protein ID93 together with the adjuvant GLA-SE.

Conditions

  • Pulmonary Tuberculosis

Interventions

BIOLOGICAL

ID93 + GLA-SE

ID93 antigen and GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.

BIOLOGICAL

ID93 alone

ID93 antigen alone. 3 injections and Days 0, 28, and 56.

Sponsors & Collaborators

  • Aeras

    collaborator OTHER

  • Paul G. Allen Family Foundation

    collaborator OTHER

  • Access to Advanced Health Institute (AAHI)

    lead OTHER

Principal Investigators

  • Franco Piazza, MD, MPH · Access to Advanced Health Institute (AAHI)

  • Anna Marie Beckmann, PhD · Access to Advanced Health Institute (AAHI)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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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 NCT01599897 on ClinicalTrials.gov