Potential new TB vaccine enters clinical trial in South Africa
23 April 2009
A new vaccine to help combat the global tuberculosis (TB) epidemic is entering the next stage of clinical trials in South Africa today. The vaccine, the most advanced of a new generation of preventive TB vaccines under development, will be tested in a Phase IIb proof-of-concept trial to ensure it is both safe and effective.
The study will be conducted by the South African Tuberculosis Vaccine Initiative of the University of Cape Town. The vaccine, called MVA85A/AERAS-485, will be given to approximately 2750 children who have already received the BCG vaccine at birth.
The new vaccine is designed to augment the body’s immune response to BCG, improving the level of protection. This is the first proof-of-concept trial of a new preventive TB vaccine in infants in more than 80 years.
MVA85A/AERAS-485 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.
Now 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 is the most clinically advanced of a number of potential TB vaccine candidates, and has been awarded orphan drug status by the European Medicines Agency.
“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.”
Tuberculosis kills 1.8 million people per year and more than 2 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.
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.
“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 and 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.”
“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.”
Image: Histopathology of pulmonary tuberculosis.
Credit: Wellcome Images