NCT02414828

A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Aeras · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

A total of 72 subjects were randomized into the study. Subjects were stratified, based on time from the start of TB treatment, into the 'on-TB-treatment' stratum (TB treatment started between 1 and 4 months prior to Study Day 0) or the 'post-TB-treatment' stratum (TB treatment started at least 12 months before Study Day 0). In the on-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=5); 1 dose of AERAS-402 at 3 x 10\^8 vp (N=5) or 3 x 10\^9 vp (N=10), or 2 doses of AERAS-402 at 3 x 10\^10 vp (N=16). In the post-TB-treatment stratum, 36 subjects were randomized to receive AERAS-402 or placebo as follows: 1 or 2 doses of placebo (N=6); 1 dose of AERAS-402 at 3 x 10\^8 vp (N=5) or 3 x 109 vp (N=10), or 2 doses of AERAS-402 at 3 x 10\^10 vp (N=15).

Conditions

• Tuberculosis

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	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.
BIOLOGICAL	AERAS-402 3 x 10^8 vp	AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
BIOLOGICAL	AERAS-402 3 x 10^9 vp	AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
BIOLOGICAL	AERAS-402 3 x 10^10 vp	AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42.

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-07-01
• Completion: 2010-11-01
• First posted: 2015-04-13
• Last updated: 2016-05-04
• Results posted: 2016-05-04

Locations

1 site across 1 country: South Africa