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A Study to Evaluate the Safety of AERAS-402 in Adults Recently Treated for Pulmonary TB — C-010-402  

Tuberculosis Clinical Trial

Official title:
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

Clinical Trial 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 days 0 and 56 of AERAS-402 or placebo.

Clinical Trial 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). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02414828
Study type Interventional
Source Aeras
Contact
Status Completed
Phase Phase 2
Start date October 2008
Completion date November 2010
View Details
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