AERAS GLOBAL TB VACCINE FOUNDATION

Developing New Tuberculosis Vaccines for the World

TB has been a scourge since ancient times, but many people are unaware of the profound impact it continues to have on individuals and societies around the world today. It kills more than 2 million people every year.

TB is more than a disease—it is also a marker for poverty. It flourishes amid such conditions as malnutrition, substandard housing, minimal health care, and/or lack of access to it. While most of the world's TB burden exists in less developed countries, no region of the world is untouched.

One third of the world's population carries the tuberculosis bacterium. Five to 10 percent of people who are infected become sick at some time during their lifetime. Spurred on by the HIV global epidemic, TB is the leading cause of death in HIV-infected individuals; one-third of people infected with HIV will develop TB. Among infectious diseases, only HIV and diarrheal diseases kill more.

A new and improved vaccine is one of the keys to controlling TB. Most forms of TB can be treated with drugs, but the complex regimen we have today takes at least six months to complete and medicine is not always available in the world's poorest countries. The current TB vaccine used throughout most of the world, BCG (Bacille Calmette-Guerin), is almost a century old and appears to have limited efficacy.

“Our goal—and we believe it is achievable—is to license and deliver a more effective TB vaccine within 10 years,” said Dr. Jerald Sadoff, president and CEO of the Aeras Global TB Vaccine Foundation, the world's only organization dedicated solely to developing new vaccines against tuberculosis. An $82.9 million grant to Aeras announced in February 2004 from the foundation will more than double the amount of money spent on TB vaccine research worldwide. “Until now, the world has devoted very few resources to the TB vaccine effort,” said Sadoff. “We have no time to lose in this pursuit. Each year without an effective vaccine means 2 million lives lost.”

Support from the foundation is enabling Aeras to dramatically expand the scope of TB vaccine development, testing updated versions of the BCG vaccine, and exploring new "prime-boost" regimens that have shown promising results in animal tests. Aeras has established a clinical research site in Cape Town, South Africa, where over 9,000 volunteers are enrolled in a trial testing different routes of administration of the existing BCG vaccine. This site will be used for Phase II and III trials of new TB vaccines, as will other sites in Asia and Latin America yet to be developed. In January 2004, Aeras began a Phase I clinical trial in the U.S. of the first live recombinant TB vaccine candidate (rBCG30).

Aeras is committed not only to increasing the pace of vaccine development, but also to operating with an industrial model that emphasizes accountability and transparency. Aeras is structured to meet realistic timelines and set clear priorities to push the most promising candidates through the vaccine pipeline. Working with scientists, companies, and governments in the U.S., Europe, South Africa, and other developing countries, Aeras is structured to promote multiple vaccine candidates simultaneously, so the best vaccine can be developed as quickly as possible.

Once a vaccine is proven safe and effective, Aeras will work to make it available at a price that developing countries can afford. “We are within reach of a vaccine that could not only save lives, but achieve the longstanding goal of bringing TB under control in the developing world,” said Sadoff. “The time has come for the world to finally defeat this disease.”