A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31)

Summary

The study has the following objectives: Primary objective To evaluate the safety profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months Secondary objective To determine the immunogenicity profile of an adjuvanted TB subunit vaccine administered in different antigen/adjuvant formulations at 0 and 2 months.

Timeline

Start

2008-12

Primary completion

2010-04

Completion

2010-04

Publications

• Hussein J, Zewdie M, Yamuah L, Bedru A, Abebe M, Dagnew AF, Chanyalew M, Yohannes AG, Ahmed J, Engers H, Doherty TM, Bang P, Kromann I, Hoff ST, Aseffa A. A phase I, open-label trial on the safety and immunogenicity of the adjuvanted tuberculosis subunit vaccine H1/IC31(R) in people living in a TB-endemic area. Trials. 2018 Jan 10;19(1):24. doi: 10.1186/s13063-017-2354-0.

Drugs

Indications