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February 2013

First TB vaccine efficacy trial in almost 100 years provides key insights

February 5, 2013 -- Results of a first-of-its-kind clinical trial of a new tuberculosis (TB) vaccine candidate show the candidate vaccine was safe and well tolerated. However, the candidate vaccine did not prevent TB disease when administered as a boost to the BCG vaccine, the currently used TB vaccine. The clinical trial of the TB vaccine candidate, called MVA85A, was a Phase IIb safety and efficacy trial in 2,797 infants living in the Western Cape province of South Africa. The candidate vaccine was safe and well tolerated in the population tested.

The successfully completed trial was a major global undertaking with the involvement and support of a large number of organizations and individuals, including:

  • The government of South Africa.
  • The South African Tuberculosis Vaccine Initiative.
  • The families and communities who participated in the trial.

Funding for the trial was provided by Aeras, along with The Wellcome Trust and the Oxford-Emergent Tuberculosis Consortium, a joint venture between the University of Oxford and Emergent BioSolutions. The vaccine was originally developed and investigated by the University of Oxford.

“This trial leaves us optimistic, Aeras Interim CEO Tom Evans said, adding, “Ten years ago, some researchers doubted the feasibility of successfully completing a study of this magnitude in a TB-endemic setting. We’ve shown that a large-scale clinical trial aimed at testing a vaccine in infants can be designed and run efficiently in a setting with a high TB burden, while also adhering to the highest standards of good clinical trial practices.”

  • To read the study in the Lancet, click here
  • To read the Lancet commentary, click here
  • To read an Aeras press release, click here
  • To read a Bloomberg article, click here

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