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

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Tuberculosis
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.

Trial Locations (1)

33100

University of Tampere Vaccine Research Clinic, Biokatu

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Statens Serum Institut

OTHER

lead

Aeras

OTHER

NCT02074956 - A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults | Biotech Hunter | Biotech Hunter