The Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd. ("the Consortium"), Isis Innovation Ltd., the Wellcome Trust and the University of Cape Town (UCT) announce today the start of a Phase IIb proof-of-concept clinical trial of a promising new TB vaccine developed at the University of Oxford called MVA85A/AERAS-485. The study will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) of UCT in the Western Cape Region from its study site 100 km from Cape Town in Worcester, South Africa. This study, which has been approved by the Medicines Control Council of South Africa, will test MVA85A/AERAS-485 in approximately 2,784 children under one year of age, all of whom have received Bacille Calmette-Guerin (BCG) at birth. It is expected that the trial will generate important safety, immunogenicity and preliminary efficacy data about the vaccine candidate. This is the first proof-of-concept trial of a new preventive TB vaccine in infants in more than 80 years.

Tuberculosis kills 1.8 million people per year and more than two billion people worldwide are infected with TB - approximately one out of every three people on the planet. New vaccines are urgently needed as part of the global response to TB. BCG is currently the only available vaccine against TB. BCG, which is administered to infants throughout the developing world and in certain countries in the developed world, provides some protection against pediatric TB. However, BCG provides only variable protection against pulmonary tuberculosis, which accounts for most of the worldwide disease burden.

"The world desperately needs new and better approaches to combat TB," said Dr. Marcos Espinal, Executive Secretary of the Stop TB Partnership. "The advancement of a new TB vaccine candidate to this stage is an exciting development for all of us who seek to end this terrible epidemic."

This new vaccine candidate is intended to augment the response of T-cells already stimulated by the BCG vaccine. Previous clinical trials of the vaccine in adults have demonstrated consistently high cellular immune responses in those who received the MVA85A/AERAS-485 vaccine candidate following vaccination with BCG.

"The search for a new TB vaccine is a complex and challenging process requiring a broad commitment, and we are pleased to be collaborating with so many dedicated and talented researchers on this important effort," said Jerald C. Sadoff, MD, President & CEO of the Aeras Global TB Vaccine Foundation. "There is still a long road ahead, but this marks an important milestone toward the goal of a more effective TB vaccine."

Wellcome Trust

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