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A Phase I/IIa AERAS-456 in HIV-Negative Adults With & Without Latent Tuberculosis Infection (C-035-456)

NCT01865487 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-12-19

Study results available
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Summary

This is a Phase I/IIa, double-blind, randomized, placebo-controlled, dose- and regimen-finding study in healthy adults with and without LTBI, who are BCG-vaccinated, HIV negative, and have no history or evidence of TB disease. The investigational product is AERAS-456 at 3 dose levels: 5, 15, and 50ug of H56 antigen with 500 nmol IC31. The vaccine is administered by IM injection.

Conditions

  • Latent Tuberculosis Bacteriology and Histology Unknown
  • Latent Tuberculosis

Interventions

BIOLOGICAL

H56ug/IC31nmol

H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant.

BIOLOGICAL

Placebo

Sterile buffer consisting of 10mM Tris and 169mM NaCl at pH 7.4

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Aeras

    lead OTHER

Principal Investigators

  • Dereck Tait, MD · Aeras

  • Angelique Luabeya, MD · University of Cape Town South African Tuberculosis Vaccine Initiative

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2015-08-31
Completion
2015-11-30

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Drugs

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 NCT01865487 on ClinicalTrials.gov