New TB Vaccine Enters Trial in South Africa
22nd April 2009
Vaccine Candidate is the most clinically advanced of a new generation of vaccines under development to combat the TB epidemic.
OXFORD, UK; ROCKVILLE, MD, USA; CAPE TOWN, ZA – 22 April 2009 – The Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd. (“the Consortium”), Oxford University Innovation Ltd., the Wellcome Trust and the University of Cape Town (UCT) announce today 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 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. Bacille Calmette-Guérin (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 pediatric 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.”
New TB Vaccine
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 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 & 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 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 Oxford University 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.”
Professor Gregory Hussey, Director of SATVI, says that the announcement of this study brings a message of hope: “We are testing the vaccine in an area burdened by one of the highest incidence rates of TB in the world, in a community most likely to benefit from its success. The study strengthens our commitment to stop TB.”
“This marks an important milestone in what we believe is an extraordinary opportunity to prevent tuberculosis, which is a major global health crisis. Emergent is proud to join such distinguished partners as we make progress in the fight against one of the world’s deadliest diseases,” said Fuad El-Hibri, Chairman and Chief Executive Officer at Emergent BioSolutions.
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