The Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd, Isis Innovation Ltd, the Wellcome Trust and the University of Cape Town (UCT) announce 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 paediatric 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 Aeras Global TB Vaccine Foundation is working with the Consortium to develop MVA85A/AERAS-485 with additional funding from the Wellcome Trust. The vaccine candidate was originally developed at the University of Oxford by Dr Helen McShane, a Wellcome Trust senior Clinical Research Fellow, working with Dr Sarah Gilbert, a Reader in Vaccinology and Professor Adrian Hill, a Wellcome Trust Principal Research Fellow. It was licensed by Isis Innovation, the University's technology transfer company to the Oxford-Emergent TB Consortium in July 2008. The vaccine has been awarded orphan drug status by the European Medicines Agency (EMEA) and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.

"We believe this is the most exciting advance in the field of TB vaccines for over 80 years," said Dr Helen McShane of the Jenner Institute, University of Oxford, "And is a testament to the commitment shown by the partners and funders involved. We have shown that this vaccine is safe and stimulates strong immune responses. This trial will hopefully show that the vaccine can protect people from getting TB and enable the global community to begin to control this devastating disease."

The Aeras Global TB Vaccine Foundation is a non-profit organization working as a Product Development Partnership to develop new tuberculosis vaccines and ensure that they are distributed to all who need them around the world.

Emergent BioSolutions Inc is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and therapeutics that assist the body's immune system to prevent or treat disease.

Isis Innovation Ltd is the University of Oxford's technology company and manages the University's intellectual property portfolio, working with University researchers on identifying, protecting and marketing technologies through licensing, spin-out company formation and material sales.

The Oxford-Emergent Tuberculosis Consortium Ltd 'OETC' is a joint venture between the University of Oxford and Emergent Product Development UK Ltd.

Wellcome Trust is the largest charity in the UK. Its mission is to fund innovative biomedical research in the UK and internationally, spending around £600 million each year to support the brightest scientists with the best ideas.