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A Study for Safety and Immunogenicity of BCG and AERAS-404 in HIV-Negative, TB-Negative, BCG-Naive Adults

NCT02420444 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-01-24

No results posted yet for this study

Summary

70 subjects received BCG intradermally at Study Day -42, then at Study Day 0 were randomized to receive AERAS-404 50 mcg H4/500 nmol IC31 intramuscularly as a 3-dose (N=30) or 2-dose (N=30) regimen, or placebo (N=10). Subjects were vaccinated on Study Days 0, 56, and 231, and followed through Study Day 259.

Conditions

Interventions

BIOLOGICAL

BCG SSI

The dose volume administered for BCG was 0.1 mL, and the mode of administration was ID injection to the deltoid area.

BIOLOGICAL

Placebo

This is the identical buffer solution in which H4:IC31 was formulated. The dose volume administered for Placebo was 0.5mL, and the mode of administration was an IM injection.

BIOLOGICAL

AERAS-404

AERAS-404 vaccine was reconstituted on site by adding 0.2 mL H4 antigen solution to 0.8 mL IC31 adjuvant solution. The dose volume administered for AERAS-404 was 0.5mL, and the mode of administration was an IM injection.

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • Aeras

    lead OTHER

Principal Investigators

  • Giuseppe Pantaleo, MD · Centre Hosptialier Universitaire Vaudois (CHUV)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-05-31
Completion
2013-11-30

Countries

  • Switzerland

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 NCT02420444 on ClinicalTrials.gov