This is a Phase I, double-blind, randomized, placebo-controlled safety and immunogenicity study in adults who have recently been successfully treated for drug-susceptible pulmonary Tuberculosis (TB). The safety and immunogenicity profile of escalating doses of AERAS-456 in HIV-negative subjects recently treated for drug-susceptible pulmonary TB will be investigated. The study will be conducted at three sites in South Africa.
This study will be the first evaluation of AERAS-456 in subjects who have completed a full course of treatment prescribed for pulmonary TB. Subjects will begin screening for study participation when they have completed 4 calendar months of TB treatment. Subjects meeting the inclusion/exclusion criteria will be randomized within a study group in a 3:1 ratio (N=18 AERAS-456; N=6 placebo) to receive two 0.5 mL intramuscular injections of AERAS-456 or placebo eight weeks apart, on Study Day 0 and Study Day 56.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
22
Task Clinical Research Centre
Bellville, Cape Town, South Africa
University of Cape Town Lung Institute
Mowbray, Cape Town, South Africa
The Aurum Institue
Johannesburg, South Africa
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Unsolicited AEs: 28 days after each vaccination Solicited AEs: 7 days after each vaccination SAEs: through Day 420 Adverse events of special interest: through Day 420
Time frame: Day 0 to Day 420
Mean Percent Change From Baseline of Participants' Responses to TB Antigens Ag85A and ESAT-6
13-Color PBMC Intracellular Cytokine Staining (ICS) Assay using PBMCs Percent Antigen-specific T Cell DMSO-subtracted, ANY Cytokine Response - Change from Baseline T Cell: CD4
Time frame: Day 224
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