Aeras Global receives FDA grant to develop biomarkers for TB vaccine

Grant for TB vaccine biomarkers with potential to speed regulatory review

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-Gu-rin 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.

"The development of biomarkers, particularly those that measure bacteriocidal effects correlated with TB vaccine effectiveness, could help shorten timeframes for introducing new TB vaccines, as we work with regulatory agencies like the FDA to conduct clinical trials and approve new TB vaccines," said Michael Brennan, PhD, Senior Advisor for Global Affairs at Aeras.

The project aims to evaluate four mycobacterial growth inhibition assays that can be reproducibly transferred to other laboratories and to identify T-cell immune and antibody responses that may be associated with ex vivo growth inhibition and potentially with protective vaccines.

The consortium is comprised of researchers at the Aeras Global TB Vaccine Foundation; the Jenner Institute, University of Oxford; the South African Tuberculosis Vaccine Initiative of the University of Cape Town; Saint Louis University; and Albert Einstein College of Medicine.