<http://schema.org/articleBody>
"<p>OXFORD, England; ROCKVILLE, Md.; CAPE TOWN, South Africa &mdash; 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.</p>\n<p>The South African Tuberculosis Vaccine Initiative of the  University of Cape Town will conduct the study in Worcester, South Africa.</p>\n<p>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-Gu&eacute;rin  (BCG) at birth.</p>\n<p>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.</p>\n<p>Tuberculosis kills 1.8 million people per year and more than 2  billion people worldwide are infected with TB &mdash; approximately one out of every  three people on the planet.</p>\n<p>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.</p>\n<p>&ldquo;The world desperately needs new and better approaches to  combat TB,&rdquo; said Dr. Marcos Espinal, executive secretary of the Stop TB  Partnership. &ldquo;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.&rdquo;</p>\n<p>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.</p>\n<p>&ldquo;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,&rdquo; said  Jerald C. Sadoff, president and CEO of the Aeras Global TB Vaccine Foundation.  &ldquo;There is still a long road ahead, but this marks an important milestone toward  the goal of a more effective TB vaccine.&rdquo;</p>\n<p>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&rsquo;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.</p>\n<p>&ldquo;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&rsquo;s deadliest diseases,&rdquo; said Fuad  El-Hibri, chairman and CEO at Emergent BioSolutions.&nbsp; <br /></p>"^^<http://www.w3.org/2001/XMLSchema#string>
<http://vaccinenewsdaily.com/stories/510530608-tb-vaccine-candidate-enters-phase-iib-proof-of-concept-trial-in-south-africa>