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Aeras-led research consortium receives FDA support
Date:10/4/2010

Rockville, MD, USA (October 4, 2010) The Aeras Global TB Vaccine Foundation is pleased to announce receipt of a grant from the United States Food and Drug Administration (FDA) to develop new biological and immunological biomarkers for TB vaccine development. The FDA grant, which supports the coordination of a multi-investigator project with researchers from the United States, the United Kingdom and South Africa, will provide $362,102 in the first year of funding. The project is anticipated to cost $785,940 over three years.

"We are grateful for this show of support from the Food and Drug Administration for TB vaccine research," said Thomas G. Evans, MD, Chief Scientific Officer of the Aeras Global TB Vaccine Foundation. "Functional and biologically relevant immunological responses that correlate with vaccine efficacy remain elusive for tuberculosis so we are fortunate to be working with leaders in bioassay research to tackle this essential component of TB vaccine development."

The global TB epidemic continues to grow more complex and difficult to treat. The currently available TB vaccine called Bacille Calmette-Gurin has limited efficacy in preventing all forms of TB. BCG was developed before modern biotechnological advances and its method of eliciting immune response is not fully understood by researchers. Currently, there are 10 investigational TB vaccines designed as boosters or potential replacements for the BCG vaccine currently undergoing or poised to enter clinical testing and many more in the product development pipeline.

To effectively assess these and future investigational TB vaccines, biomarkers correlated with vaccine effectiveness are needed. A biomarker would facilitate clinical studies of vaccines across research institutions, geographic locations and within different target age groups and populations, standardizing and streamlining the regulatory review of clinical trial data.

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Contact: Annmarie Leadman
aleadman@aeras.org
240-599-3018
Aeras Global TB Vaccine Foundation
Source:Eurekalert

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