Rockville, MD, & Seattle, WA, USA (August 22, 2012) – Aeras and the Infectious Disease Research Institute (IDRI) announce today the start of the first clinical trial of IDRI's novel tuberculosis vaccine candidate, ID93 + GLA-SE. The Phase I clinical trial will assess the safety, tolerability and immunogenicity of the vaccine candidate in 60 healthy adult volunteers. The study will be conducted by Johnson County Clin-Trials in Lenexa, Kansas, in close collaboration with Aeras and IDRI.
Tuberculosis (TB), which kills more people than any other infectious disease except HIV, has orphaned 10 million children, and costs the global economy an estimated $1 billion every day. An increasing number of diagnosed multidrug-resistant TB cases are making the disease more difficult to control and multiplying the cost and time it takes to treat patients, which can take two years or longer for multidrug-resistant TB.
The vaccine candidate targets both active tuberculosis, which makes nearly 9 million people sick each year, and latent TB, which lies dormant in one-third of the world's population and reactivates when their immune systems are compromised.
"An effective TB vaccine for adolescents and adults would be the single most cost-effective intervention against tuberculosis," said Tom Evans, Aeras Chief Scientific Officer. "With cases of drug-resistant TB on the rise, it is urgent to deliver an effective TB vaccine regimen to those who need it as soon as possible."
The vaccine candidate, ID93 + GLA-SE, is composed of a recombinant fusion-protein antigen designed by IDRI to recognize both active and latent TB, plus IDRI's proprietary adjuvant, GLA-SE, which has been previously tested in humans. In pre-clinical studies, the vaccine candidate had an acceptable safety profile in animals and demonstrated substantial protection against Mycobacterium tuberculosis – the bacterium that causes TB.
"With NIH support enabling our TB program, IDRI has designed and tested the safety and efficacy of this vaccine candidate in several pre-clinical models," said Steven Reed, Ph.D., IDRI president, founder and Chief Scientific Officer. "The start of the first clinical trial is a significant milestone following nearly seven years of work on this vaccine candidate, which is designed to produce a robust immune response to prevent, and possibly to treat, TB."
The currently available TB vaccine, Bacille Calmette-Guérin (BCG), developed 90 years ago, reduces the risk of severe forms of TB in early childhood but has been ineffective in controlling the global TB epidemic despite widespread use. Aeras and IDRI, two non-profit product development partnerships, are committed to making new TB vaccines available to those who need them most in TB endemic countries.
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 ID93 + GLA-SE
ID93 + GLA-SE is an investigational vaccine for the prevention of tuberculosis (TB). The vaccine consists of ID93, which is a recombinant fusion polyprotein comprised of Mycobacterium tuberculosis antigens associated with virulence or latency (Rv2608, Rv3619, Rv3620, and Rv1813) and Glucopyranosyl Lipid A – Stable Emulsion (GLA SE) as an immunological adjuvant. GLA is a Toll-like receptor 4 (TLR4) agonist that is formulated in an oil-in-water emulsion (SE).
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.
The Infectious Disease Research Institute (IDRI) is a Seattle-based not-for-profit organization committed to applying innovative science to the research and development of products to prevent, detect, and treat infectious diseases of poverty. By integrating capabilities, including early stage drug discovery, preclinical testing, manufacturing, and clinical trials, IDRI strives to create an efficient pathway bringing scientific innovation from the laboratory to the people who need it most. For more information about IDRI's Tuberculosis program, please visit www.idri.org.
The preclinical studies of ID93/GLA-SE were funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, under contract HHSN272200800045C and grant 5U01AI078054.
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