New tuberculosis vaccine begins trial in South Africa

28 Apr 2009

Paul Chinnock

Source: Wellcome Trust (see original article)

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A new tuberculosis vaccine, which would be given alongside the vaccine already used against the disease (BCG), has begun a clinical trial in South Africa. Some 2750 children, who have already been given BCG at birth, will participate in the trial. The aim is to have the vaccine ready for use in public health programmes by 2016.

The new MVA85A vaccine is regarded as the most advanced of a new generation of preventive TB vaccines under development. Earlier trials have shown the vaccine to be safe. The new study, which will be conducted by the South African Tuberculosis Vaccine Initiative of the University of Cape Town, is described as a “Phase IIb proof-of-concept trial”. It is the first such trial of a TB vaccine for over 80 years.

MVA85A was originally developed at the University of Oxford by Dr Helen McShane, Dr Sarah Gilbert and Professor Adrian Hill, with funding from the Wellcome Trust. It was licensed to the Oxford-Emergent TB Consortium in July 2008. Now the Aeras Global TB Vaccine Foundation is working with the Consortium to develop MVA85A/AERAS-485, with further Wellcome support. It has been awarded orphan drug status by the European Medicines Agency.

Helen McShane said, “We believe this is the most exciting advance in the field of TB vaccines for over 80 years 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.”

Dr Jerald Sadoff, President and CEO of the Aeras Global TB Vaccine Foundation commented, “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.”

“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.”

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

See also previous TropIKA.net new stories (1, 2) on the MVA85A vaccine.