MedTrace Logo

A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection

NCT02066428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2014-02-19

No results posted yet for this study

Summary

Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile females.

Conditions

Interventions

BIOLOGICAL

AERAS-404

AERAS 404 (H4:IC31) contains a fusion protein of 2 mycobacterial antigens (Ag85B and TB 10.4) formulated in IC31 adjuvant.

BIOLOGICAL

Placebo

Tris buffer saline consisting (10mM Tris and 169mM NaCI at pH7.4)

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Aeras

    lead OTHER

Principal Investigators

  • Zhongkai SHI, MD · Aeras

  • Jan Andersson, MD · Karolinska Institutet

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
2007-11-30
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • Sweden

Study Locations

More Related Trials

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 NCT02066428 on ClinicalTrials.gov