Location: Rockville, Maryland, United States
Issue Areas: Health Education, Medical Biotechnology, Public Health, Tuberculosis

Aeras Global TB Vaccine Foundation was founded in 1997 to help develop new concepts and tools to control the global TB epidemic. Today the organization focuses solely on developing new vaccines against TB and ensuring their availability to all who need them. In February 2004, Aeras received a 5-year US$82.9 million grant from the Bill & Melinda Gates Foundation for new TB vaccine development and recently received funding from the U.S. Centers for Disease Control and Prevention and the Government of Denmark.

It is the goal of Aeras to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine within 10 years.

Although a foundation in name, Aeras is not a grant-making organization. Instead, Aeras actively pursues and helps fund joint development activities with leading TB vaccine developers around the world and also develops candidate vaccines in its own laboratory.

Under the scrutiny of independent vaccine development experts, Aeras takes promising research and early development candidates through preclinical regulatory requirements, clinical Phase I, II and III studies, process development, manufacturing and release. The aim of all of these activities is to license affordable, effective TB vaccines that Aeras or one of its partners will make available through a variety of distribution channels to people in the developing world.

The overall scientific strategy is to improve the current, widely used Bacille Calmette-Guerin (BCG) vaccine that has limited efficacy and boost this improved BCG vaccine with either a recombinant TB protein plus adjuvant or a recombinant viral vector making TB antigens. Prime-boost regimens of this sort have proven to be the most powerful inducers of immune responses and protection against tuberculosis in animal models.

In 2004 Aeras performed the preclinical evaluation and regulatory activities for a new recombinant BCG vaccine developed by Dr. Marcus Horwitz at UCLA and sponsored a Phase I trial of the vaccine. Aeras is working with Crucell NV to develop and test Adeno35 vectored vaccines and with Statens Serum Institut on a second-generation fusion-protein vaccine. Other collaborations with leading vaccine developers are in progress and will be announced when arrangements are finalized.

Aeras has worked for several years with the University of Cape Town to establish a clinical research site near Cape Town, South Africa. This site along with another being developed in southern India with St. John’s Medical College, Bangalore, will be used for clinical trials of candidate vaccines.

Aeras is led by Dr. Jerald Sadoff, MD, who has worked in vaccine development for more than 30 years. Before joining Aeras as President & CEO in 2003, Dr. Sadoff served as clinical director for vaccine development at Merck and Director of the Division of Communicable Diseases and Immunology at the Walter Reed Army Institute of Research.