Advanced Tuberculosis Vaccine receives Wellcome boost

The Wellcome Trust and Aeras Global TB Vaccine Foundation have agreed to provide GBP 8 million in funding for Phase IIb clinical trial that is expected to commence in 2009. The vaccine candidate, MVA85A, has been granted orphan drug designation by the European Medicines Agency (EMEA). If successful, MVA85A would be the first new vaccine licensed to prevent tuberculosis in over 80 years according to a press release by Emergent BioSolutions Inc. The clinical trial will take place in Cape Town.

On the face of it this is good news. Tuberculosis is the most common cause of death in people living with HIV in Africa and a major cause of death elsewhere. The number of new cases of tuberculosis has more than doubled in countries with high HIV prevalence in the past 15 years according to the press release. However, problems with access to drugs and counterfeits on the continent threaten to erode the benefits of this initiative.

The University of Oxford and Emergent BioSolutions Inc. announced that they have formed a joint venture, The Oxford-Emergent Tuberculosis Consortium Ltd. (the "Consortium"), to further develop MVA85A, the world's most clinically advanced vaccine candidate for the prevention of tuberculosis. The University of Oxford, through its technology transfer office, Isis Innovation Limited, has exclusively licensed the MVA85A tuberculosis vaccine candidate and related technology to the Consortium. The Consortium will work with the Aeras Global TB Vaccine Foundation to evaluate the efficacy of MVA85A in infants in a Phase IIb clinical trial anticipated to begin in 2009. The trial will take place at a clinical trial site developed by Aeras and the University of Cape Town's South African Tuberculosis Vaccine Initiative (SATVI) in Worcester, South Africa. The Consortium has secured GBP 8 million (approximately $16 million) from The Wellcome Trust and the Aeras Global TB Vaccine Foundation to fund this Phase IIb trial. Under agreements with the Consortium, Emergent BioSolutions has the rights to commercialize the MVA85A vaccine. The Aeras Global TB Vaccine Foundation will have distribution rights in the developing world to ensure availability and access to the vaccine to those who need it.