Friday, April 24, 2009

TB vaccine enters clinical Trials at Oxford

. Friday, April 24, 2009

A promising new tuberculosis vaccine developed by the Oxford University which would protect people from getting the killer disease has reached 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 study will be conducted in South Africa, around 100 km from Cape Town, by the South African Tuberculosis Vaccine Initiative (SATVI).

We believe this is the most exciting advance in the field of TB vaccines for over 80 years and it is a testament to the commitment shown by the partners and funders involved Helen McShane of the Jenner Institute, University of Oxford, said.

"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 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. There is still a long road ahead, but this marks an important milestone toward the goal of a more effective TB vaccine," added Jerald C Sadoff, MD, President & CEO of the Aeras Global TB Vaccine Foundation.

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.

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.

he 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.

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