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A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults

NCT02074956 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-03-17

No results posted yet for this study

Summary

This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative, and have no evidence of tuberculosis infection. Since BCG-vaccinated individuals are the target population for which AERAS 404 might be indicated, AERAS 404 will be administered to individuals already vaccinated with BCG

Conditions

Interventions

BIOLOGICAL

AERAS-404

AERAS-404 is comprised of the H4 antigen, a fusion protein of Mycobacterium tuberculosis antigens 85B and TB10.4; and IC31 adjuvant, a combination of a leucine-rich peptide and a synthetic oligonucleotide.

BIOLOGICAL

Placebo

Sterile buffer containing 10 mmol Tris and 169 mmol of NaCl in 0.8 mL of aqueous solution. This is the identical buffer solution in which H4 and IC31 are formulated.

Sponsors & Collaborators

  • Statens Serum Institut

    collaborator OTHER

  • Aeras

    lead OTHER

Principal Investigators

  • Zhongkai Shi, MD · Aeras

  • Timo Vesikari, MD · University of Tampere Vaccine Research Clinic

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
2008-05-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Finland

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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 NCT02074956 on ClinicalTrials.gov