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

NCT02414828 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-05-04

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Crucell Holland BV

    collaborator INDUSTRY

  • Aeras

    lead OTHER

Principal Investigators

  • Eric Bateman, MD · University of Cape Town Lung Institute Pty (Ltd)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-07-31
Completion
2010-11-30

Countries

  • South Africa

Study Locations

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Entities

Drugs
Diseases

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 NCT02414828 on ClinicalTrials.gov