The killer of Keats, Chopin, and Eleanor Roosevelt, tuberculosis (TB) has been a scourge for over 200 years, but many people are unaware of its profound impact on individuals and societies around the world today.

TB is more than a disease—it is a marker for poverty, flourishing amid conditions such as malnutrition, substandard housing, and minimal health care. While most of the world’s TB burden exists in less-developed countries, no region of the world is untouched.

In a world that is increasingly connected by conflict as well as industry, TB is a growing menace, killing nearly two million people every year and trapping entire societies in a cycle of poverty and disease. 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; in fact, one-third of people infected with HIV will develop TB. Among infectious diseases, only HIV and diarrheal diseases kill more people. 

As TB principally attacks young people during their most productive years, communities can find themselves in a cycle of disease and poverty. When a family member becomes ill and cannot work, the family must absorb costs and lose months of income. If the individual dies, the family may lose up to 15 years of income.

A new, improved vaccine is one of the keys to controlling TB, which often begins with a nagging cough, but can spread through the lungs to the bones and the brain. Most forms of TB can be treated with drugs, but the complex regimen 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, Bacille Calmette-Guerin (BCG), 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. Aeras is the world’s only organization dedicated solely to developing new vaccines for tuberculosis. Two grants to Aeras totaling $283 million from the Bill & Melinda Gates Foundation have helped significantly increase the amount of money spent on TB vaccine research worldwide.

“Until now, the world has devoted very few resources to the TB vaccine effort,” Dr. Sadoff said. “We have no time to lose in this pursuit. Each year without an effective vaccine means two million lives lost."

Sadoff has obtained licenses for five different vaccines over the span of his career. He said he was most emotionally committed to this project. “No new TB vaccine made with modern technology has entered Phase II or III clinical trials. This must and will change," he added.

Support from the Gates Foundation is enabling Aeras to dramatically expand the scope of TB vaccine development. The organization is 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. This site will be used for Phase II and III trials of new vaccines, as will other sites in Asia and Latin America. 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 to increasing the pace of vaccine development and to operating with an industrial model that emphasizes accountability and transparency. Aeras is structured to meet realistic timelines and sets clear priorities to push the most promising candidates through the vaccine pipeline. Working in collaboration 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 Dr. Sadoff. “The time has come for the world to finally defeat this disease.”

Profile
Dr. Jerald C. Sadoff, M.D., President & CEO, Aeras Global TB Vaccine Foundation

Dr. Jerald C. Sadoff has spent more than three decades developing vaccines for dozens of diseases from chicken pox to malaria. As the former clinical director for vaccine development at Merck, Dr. Sadoff led the effort to develop and license a vaccine that prevents against hepatitis A. He also obtained licenses for a combination vaccine that prevents six different diseases, including hepatitis B, hemophilus influenza b, whooping cough, polio, tetanus, and diphtheria. He played a leading role in Merck’s HIV, rotavirus, herpes zoster, MMR/Varicella combination, and human papilloma virus programs.

Sadoff is an avuncular, passionate man who glows with pride when describing how his granddaughter received the Hib vaccine he developed and licensed when at Merck.  Before joining Merck, he was director of the Division of Communicable Diseases and Immunology at the Walter Reed Army Institute of Research, where he worked on vaccines against bacterial, viral, and parasitic diseases, including sepsis, gonorrhea, cholera, shigella, dengue, HIV, and malaria.

Aeras hired Dr. Sadoff in 2003 to lead the effort to develop new TB vaccines. The Aeras Global TB Vaccine Foundation (formerly known as the Sequella Global Tuberculosis Foundation) was founded in 1997 by Dr. Carol Nacy to develop new tools to fight the global TB epidemic. 

Updated September 2007