TB vaccine candidate enters Phase IIb proof-of-concept trial in South Africa

OXFORD, England; ROCKVILLE, Md.; CAPE TOWN, South Africa — The Aeras Global TB Vaccine Foundation, the Oxford-Emergent Tuberculosis Consortium Ltd., Isis Innovation Ltd., the Wellcome Trust and the University of Cape Town announce April 22, 2009, the start of a Phase IIb proof-of-concept clinical trial of a new TB vaccine developed at the University of Oxford called MVA85A/AERAS-485.

The South African Tuberculosis Vaccine Initiative of the University of Cape Town will conduct the study in Worcester, South Africa.

This study, which has been approved by the Medicines Control Council of South Africa, will test MVA85A/AERAS-485 on approximately 2,800 children younger than 1 year, all of whom have received Bacille Calmette-Guérin (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 2 billion people worldwide are infected with TB — approximately one out of every three people on the planet.

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.”

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, 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 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 developed at the University of Oxford. It was licensed by Isis 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 and is the most clinically advanced of a new generation of tuberculosis vaccine candidates.

“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 CEO at Emergent BioSolutions.