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TB Vaccine Enters new Clinical Trials Health

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A Gambian infant is inoculated as part of a previous MRC study with the MVA85A vaccine. The world’s leading candidate for a tuberculosis vaccine, developed at the University of Oxford, is to enter Phase IIb proof-of-concept clinical trials, making it the first TB candidate vaccine for more than 80 years to get to this advanced stage of clinical trials in infants.

More than two billion people are infected with tuberculosis (TB) – approximately one out of every three people on the planet – and 1.8 million die annually from the disease.

Oxford researchers have developed a promising new vaccine against TB. The Oxford-Emergent Tuberculosis Consortium Ltd, a joint venture between the University of Oxford and Emergent BioSolutions Inc, is taking the vaccine forward.

The announcement of the next phase of trials was made by the Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd, Isis Innovation, the Wellcome Trust and the University of Cape Town (UCT). The study will be conducted in South Africa, around 100 km from Cape Town, by the South African Tuberculosis Vaccine Initiative (SATVI) of UCT.

A new vaccine is urgently needed, as BCG is currently the only available vaccine against TB, and provides only variable protection against pulmonary tuberculosis, which accounts for most of the worldwide disease burden.

The trial will enrol 2,784 children less than one year of age, all of whom have received BCG at birth. It is expected that the trial will generate important safety, immunogenicity and preliminary efficacy data about the vaccine candidate.

The Aeras Global TB Vaccine Foundation is working with the Consortium to develop the vaccine, called 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 Tuberculosis 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.