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news.The Oxford-Emergent Tuberculosis Consortium, the Aeras Global TB Vaccine Foundation, Isis Innovation, the Wellcome Trust and the University of Cape Town have announced 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.
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The study will be conducted by the South African Tuberculosis Vaccine Initiative (SATVI) of University of Cape Town in the Western Cape Region from its study site 100km 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 Bacille Calmette-Guerin (BCG) at birth.
It is expected that the trial will generate important safety, immunogenicity and preliminary efficacy data about the vaccine candidate. This is reported to be the first proof-of-concept trial of a new preventive TB vaccine in infants in more than 80 years.
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, said Emergent.
The Aeras Global TB Vaccine Foundation is working with the Oxford-Emergent Tuberculosis 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 Helen McShane, a Wellcome Trust senior clinical research fellow, working with Sarah Gilbert, a reader in vaccinology and Adrian Hill, a Wellcome Trust principal research fellow.
It was licensed by Isis Innovation, the university’s technology transfer company to the Oxford-Emergent Tuberculosis Consortium in July 2008. The vaccine has been awarded orphan drug status by the European Medicines Agency and is reported to be the most clinically advanced of a new generation of tuberculosis vaccine candidates.
Fuad El-Hibri, chairman and CEO at Emergent BioSolutions, said: “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.”