The Aeras Global TB Vaccine Foundation was founded in 1997 to develop new concepts and tools to control the global TB epidemic. It is the goal of Aeras to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 10 years.

In partnership with the Aeras Global TB Vaccine Foundation, Crucell is developing a recombinant vaccine against tuberculosis. The Crucell-Aeras TB vaccine program focuses on improvement of the only currently available TB vaccine, the Bacillus Calmette-Guérin (BCG) vaccine. Aeras and Crucell began jointly developing this vaccine candidate, called AERAS-402, in 2004. Data from completed AERAS-402/Crucell Ad35 trials support the immunogenicity and acceptable safety profile of this candidate at all dose levels evaluated.

Completed Phase I trials:

USA: safety;

South Africa: high CD8-cell immune response;

St. Louis, USA: immunogenic response for boost doses;

Kenya: no safety issues for AERAS-402 in BCG-vaccinated adults.

Ongoing Phase I trials:

South Africa: vaccine safety in infants previously vaccinated with BCG vaccine.

Ongoing Phase II trials:

South Africa: safety in adults who have had active TB.

GSK Biologicals is developing a prophylactic vaccine to prevent mycobacterium tuberculosis disease in infants, adolescents and adults. The company's candidate vaccine is composed of the M72 antigen and GSK's proprietary AS01 adjuvant system. In a BCG prime-boost regimen, the candidate vaccine has been shown to improve the protection conferred by BCG and confer a long-term protection in monkeys primed with BCG and challenged with a high dose of virulent mycobacterium tuberculosis.

Completed Phase I/II clinical trials:

Belgium and South Africa: PPD-negative adults;

South Africa and the Philippines: PPD-positive adults;

Switzerland: HIV positive individuals under HAART.

Clinical trials are ongoing to evaluate the safety and immunogenicity of the candidate vaccine in adolescents, infants and HIV treatment naive adults, som in partnership with Aeras global TB foundation and TBVAC. The ultimate aim of these partnerships is to accelerate the vaccine development to ensure rapid access to the populations who need it most.