Phase II Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of H1/IC31®, an adjuvanted TB Subunit Vaccine, in HIV-Infected Adults with CD4+ Lymphocyte Counts Greater than 350 cells/mm3

Funding: EDCTP


Bacille Calmette Guerin (BCG) remains the only approved vaccine against TB and more than 3 billion people have received BCG to date. However, while studies have repeatedly demonstrated that vaccination with BCG in infancy is highly effective against TB in children, the major burden of TB is associated with pulmonary disease in later life, against which the vaccine has proven less effective. There is thus a need for a new, effective boost or therapeutic TB vaccine in adults that can be made available to low income settings.

This project is built around a Phase II study of the TB vaccine trial and ancillary studies that will be conducted in collaboration with the TB vaccine product manufacturers Statens Serum Institut (Sponsor),  The Aurum Institute in South Africa, the Ifakara Health Institute in Tanzania, KNCV in the Netherlands and the Swiss Tropical and Public Health Institute.

The objectives of the Phase II trial are to evaluate the safety and the immunogenicity of H1/IC31® in adult subjects with CD4+ lymphocyte counts greater than 350 cells/mm3 and no evidence of active TB disease. The Ag85B-ESAT-6 candidate vaccine has been designed with a strong Th1 adjuvant, IC31, and induces a strong persisting Th1 response as shown in previous Phase I trials.