NCT02066428View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Tuberculosis
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)

Trial Locations (1)

14186

Karolinska Institutet, Karolinska University Hospital, Huddinge

Sponsors

Lead Sponsor

Aeras
All Listed Sponsors
collaborator

Statens Serum Institut

OTHER

lead

Aeras

OTHER

NCT02066428 - 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 | Biotech Hunter | Biotech Hunter