Aeras Global TB Vaccine Foundation
Encyclopedia
Aeras is a non-profit Product Development Partnership (PDP) dedicated to the development of effective tuberculosis
vaccine
regimens that will prevent TB infection in all age groups and will be affordable, available and adopted worldwide. Founded in 2003, Aeras is located in Rockville, Maryland
, USA.
The only existing vaccine against TB is the Bacille Calmette-Guérin (BCG) vaccine, which is over 80 years old. Unfortunately, it is only partially effective; it provides some protection against severe forms of pediatric TB, but is unreliable against adult pulmonary TB, which accounts for most of the disease burden worldwide. There is therefore an urgent need for a modern, safe and effective vaccine that would prevent all forms of TB, including the drug-resistant strains, in all age groups and among people with HIV.
Aeras believes the most effective vaccine regimen will utilize the "prime-boost" strategy of vaccination. This involves an initial “prime” inoculation given at a very young age, followed by a “boost” given some time later. It is hoped that this strategy will not only increase the quality of protection, but will extend the duration of protection as well .
Using the prime-boost regimen as the guiding principle of its discovery work, Aeras has made creating a modern version of the existing BCG its highest priority. By genetically modifying the existing strain, Aeras has created several recombinant
BCGs, including AERAS-rBCG, that overexpress selected antigens and promote endosome escape, thereby enhancing immunogenicity. Antigen overexpression has been validated in proof of principle studies in humans, where the resulting rBCGs induced higher levels of functional antigen specific T cells than its parent BCG . Additionally, in non-human primate studies, Aeras has demonstrated that endosome escape vaccines that also overexpress TB antigens induce increased cellular responses compared to the current BCG.
to provide further training and the construction of modern laboratory and health facilities at each site.
Tuberculosis
Tuberculosis, MTB, or TB is a common, and in many cases lethal, infectious disease caused by various strains of mycobacteria, usually Mycobacterium tuberculosis. Tuberculosis usually attacks the lungs but can also affect other parts of the body...
vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...
regimens that will prevent TB infection in all age groups and will be affordable, available and adopted worldwide. Founded in 2003, Aeras is located in Rockville, Maryland
Rockville, Maryland
Rockville is the county seat of Montgomery County, Maryland, United States. It is a major incorporated city in the central part of Montgomery County and forms part of the Baltimore-Washington Metropolitan Area. The 2010 U.S...
, USA.
Need for TB Vaccines
Someone in the world is infected with tuberculosis every second. 2 billion people worldwide are infected with TB — about one out of every three people on the planet. Of these, nearly 1.8 million die a year from TB. Multidrug-resistant (MDR) and extensively drug resistant (XDR) tuberculosis is becoming a threatening issue in the developed countries as well.The only existing vaccine against TB is the Bacille Calmette-Guérin (BCG) vaccine, which is over 80 years old. Unfortunately, it is only partially effective; it provides some protection against severe forms of pediatric TB, but is unreliable against adult pulmonary TB, which accounts for most of the disease burden worldwide. There is therefore an urgent need for a modern, safe and effective vaccine that would prevent all forms of TB, including the drug-resistant strains, in all age groups and among people with HIV.
Mission
Aeras' mission is to develop, test, characterize, license, manufacture and distribute at least one new TB vaccine regimen for infants and another for adolescents within 8–10 years and ensure its availability to all who need them.Objectives
Aeras has three main objectives. First, to advance the world's leading TB vaccine candidates forward towards licensing and availability by reviewing data from clinical trials and selecting only the most promising candidates for large-scale Phase III trials. Second, to rationalize the TB vaccine development process by attempting to validate animal models and immunologic markers capable of predicting vaccine induced protection in humans, which will make expedite development of more effective vaccines in the future. And third, to maintain a robust TB vaccine pipeline so that subsequent generations of better vaccines that prevent reactivation of latent infection will be brought forward.Funding
Aeras receives funding from a number of donors. In 2007, The Bill and Melinda Gates Foundation announced $200 million grant to continue research for the next five years and has been a major donor since its inception . Other major donors include the Netherlands Ministry of Foreign Affairs, the Centers for Disease Control, the Danish International Development Agency, and the Research Council of Norway.Vaccine Development
Aeras currently has six vaccines in its pipeline, two of which are being manufactured at Aeras headquarters. The other four are being produced in collaboration with Aeras' partners throughout the world.Aeras believes the most effective vaccine regimen will utilize the "prime-boost" strategy of vaccination. This involves an initial “prime” inoculation given at a very young age, followed by a “boost” given some time later. It is hoped that this strategy will not only increase the quality of protection, but will extend the duration of protection as well .
Using the prime-boost regimen as the guiding principle of its discovery work, Aeras has made creating a modern version of the existing BCG its highest priority. By genetically modifying the existing strain, Aeras has created several recombinant
Recombinant DNA
Recombinant DNA molecules are DNA sequences that result from the use of laboratory methods to bring together genetic material from multiple sources, creating sequences that would not otherwise be found in biological organisms...
BCGs, including AERAS-rBCG, that overexpress selected antigens and promote endosome escape, thereby enhancing immunogenicity. Antigen overexpression has been validated in proof of principle studies in humans, where the resulting rBCGs induced higher levels of functional antigen specific T cells than its parent BCG . Additionally, in non-human primate studies, Aeras has demonstrated that endosome escape vaccines that also overexpress TB antigens induce increased cellular responses compared to the current BCG.
Trial Sites
In preparation for large-scale vaccine trials, Aeras has developed study sites at several locations worldwide. These clinical trial field sites have been established in Worcester, South Africa; Kampala, Uganda; Kisumu, Kenya; and Bangalore, India in preparation for Phase I-III trials. At each site, Aeras has developed a Professional Development Program to boost the community health-care infrastructure. All members of the local research team are provided with a core foundation of knowledge and skills in the management of clinical trials and infectious diseases. To date, over 300 participants have completed the program. Additionally, Aeras works with South African Tuberculosis Vaccine Initiative and the George Washington UniversityGeorge Washington University
The George Washington University is a private, coeducational comprehensive university located in Washington, D.C. in the United States...
to provide further training and the construction of modern laboratory and health facilities at each site.