Multi-site study underway in Africa
ROCKVILLE, MD, USA, August 28, 2014 – Aeras today announced the initiation of a large, multi-country Phase IIb clinical trial to evaluate the ability of a novel vaccine candidate to prevent tuberculosis disease in adults.
Aeras and GlaxoSmithKline Vaccines, S.A. (GSK) will jointly conduct the double-blind, randomised, placebo-controlled study (ClinicalTrials.gov Identifier: NCT01755598) to evaluate the efficacy, safety and immunogenicity of GSK’s proprietary vaccine candidate M72/AS01E*. The trial will enroll more than 3500 healthy adults, with latent (asymptomatic) TB infection (LTBI), ages 18-50, in TB-endemic sub-Saharan African countries, starting in South Africa. Subjects will be enrolled in 2014 and 2015, with a 36-month follow-up, yielding study results in 2018.
“Nearly nine million people become ill with tuberculosis disease each year. An effective vaccine to prevent TB disease would have a dramatic impact on quality of life around the world, particularly in the regions where TB disease is most rampant – Asia and Africa,” said Thomas G. Evans, MD, Aeras President and CEO.
TB is one of the most deadly infectious diseases in the world. A TB patient with active disease can infect up to 15 people simply by coughing, sneezing or talking. The emergence and spread of drug-resistant forms of TB are expensive and difficult to diagnose and treat, complicating multinational efforts to control the global epidemic. Bacille Calmette-Guerin (BCG), the only current TB vaccine, is one of the most widely administered vaccines globally. While it prevents some forms of TB in young children, most of the spread of TB comes from adults, and BCG’s widespread use in infants has failed to control the global epidemic. Revaccination of adolescents and adults with BCG does not appear in multiple studies to be an effective approach to TB control.
The most effective way to stop an epidemic like TB is to prevent its spread. As with every other major infectious disease in the history of mankind, prevention through vaccination would be the most cost-effective tool in eradicating disease burden. An effective TB vaccine for adolescents and adults is crucial to get ahead of transmission and drive game-changing reductions in disease burden.
GSK’s proprietary vaccine candidate M72/AS01E comprises an immunogenic fusion protein (M72) derived from two M. tuberculosis antigens (Mtb32 and Mtb39), evaluated in human and animal studies over several years and the AS01E adjuvant system. In early clinical trials, this vaccine has proven effective in mobilizing immune cells believed to play a key role in protecting against TB disease.
Aeras is a nonprofit biotech advancing the development of tuberculosis vaccines for the world. In collaboration with global partners in Africa, Asia, North America and Europe, Aeras is supporting the clinical testing of six experimental vaccines as well as a robust portfolio of earlier stage candidates. Aeras receives funding from the Bill & Melinda Gates Foundation, the UK Department for International Development, the Netherlands’ Ministry of Foreign Affairs, Australian AID, and a range of other governments. Aeras is based in Rockville, Maryland; Cape Town, South Africa; and Beijing, China. www.aeras.org
* The GSK proprietary AS01E adjuvant system contains QS-21 Stimulon® adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. (NASDAQ: AGEN), MPL and liposomes.