FDA provides grant in support of TB vaccine development
Aeras-led consortium to advance human assay studies
The United States Food and Drug Administration (FDA) has awarded Aeras a $299,525 grant to support the discovery of biological and immunological biomarkers for TB vaccines. This funding will be used to continue assessments of a novel mycobacterial growth inhibition assay that could drastically reduce the time and cost of developing new vaccines against tuberculosis.
“Next to new vaccines, no tool is more important to the TB vaccine field than the identification of an assay that can reproducibly predict whether a vaccine will work in human populations,” said Mike Brennan, PhD, Senior Advisor of Global Affairs at Aeras. “The FDA has recognized this and through its innovative Critical Path Program has provided significant support to make the development of this new tool a reality.”
The FDA has already awarded Aeras $553,425 over the past two years for this project, which is being executed in collaboration with researchers at St. Louis University, the University of Oxford, the Albert Einstein College of Medicine and the South African Tuberculosis Vaccine Initiative (SATVI). Although developed primarily as an assay to measure the effects of new TB vaccines in humans, the assay has also been adapted for use in preclinical animal models of TB and could provide a faster and less costly approach to TB challenge studies than current methods used to screen for vaccine efficacy and immunogenicity.
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About Tuberculosis
According to the World
Health Organization (WHO), one-third of the world’s
population is infected with latent M. tuberculosis. Nearly nine
million people became sick with TB and 1.4 million people died
from TB in 2010. Current guidelines require a minimum of six to
nine months of treatment. TB is changing and evolving, making
new vaccines more crucial for controlling the pandemic. TB is
the leading cause of death for people living with HIV/AIDS,
particularly in Africa. Multidrug-resistant TB (MDR-TB) and
extensively drug-resistant TB (XDR-TB) are hampering treatment
and control efforts.
About Aeras
Aeras is the world’s
largest and only fully integrated tuberculosis vaccine
development organization dedicated to addressing a pathogen that
has chronically infected almost a third of the world’s
population. In collaboration with global partners in Africa,
Asia, North America and Europe, Aeras is supporting the clinical
testing of six vaccine candidates as well as a robust portfolio
of pre-clinical candidates. Aeras is a non-profit organization
and receives funding from the Bill & Melinda Gates
Foundation and other private foundations as well as a wide range
of governments. Aeras is based in Rockville, Maryland, USA where
it operates a state-of-the-art manufacturing and laboratory
facility, and Cape Town, South Africa. For more information, see
www.aeras.org.
Aeras
