At a glance
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A Phase II Double-Blind, Randomized, Placebo-controlled, Dose Escalation Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary Tuberculosis
In Brief
A Phase 2 clinical trial evaluating Placebo, AERAS-402 3 x 10^8 vp, and 2 other interventions for Tuberculosis. Completed, enrolled 72 participants across 1 site.
Detailed Summary
This was a double-blind, randomized, placebo-controlled dose-escalation study in adults recently treated for pulmonary TB. The dose of AERAS-402 increased in successive dose groups. Enrollment into a dose group was sequential. Enrollees were stratified based on time from the start of TB treatment. The "on-TB-treatment" stratum started TB treatment between 1 and 4 months (30 to 120 calendar days) prior to Study Day 0. The "post-TB-treatment" stratum started TB treatment at least 12 months (360 calendar days) prior to Study Day 0. Subjects were randomized to receive a placebo or AERAS-402 vaccine. In Dose Groups 1 and 2, subjects were randomized to receive a single injection of AERAS-402 or placebo. Dose Group 3 subjects were randomized to receive two injections on study day 0 and study day 42 of AERAS-402 or placebo.
Study Details
Timeline
Interventions
This is the identical buffer solution in which AERAS-402 is formulated. The placebo (1.0 mL volume) was administered by intramuscular (IM) injection to the deltoid area on Study Day 0 for groups 1 and 2 and Study Day 0 and 42 for group 3.
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42.