LONDON (Reuters) - GlaxoSmithKline and the non-profit biotech group Aeras are to assess an experimental tuberculosis vaccine in “proof of concept” tests in Africa and India, marking a step forward in the hunt for new ways to prevent the killer disease.
The partners plan to launch a mid-stage Phase IIb clinical study in Kenya, South Africa and India next year, following successful initial tests with the GSK product, Aeras said on Wednesday.
TB is a growing threat around the world, especially with the emergence of strains that are resistant to multiple antibiotics. It kills an estimated 1.4 million people a year.
The disease is spreading despite the widespread use of the currently available TB vaccine, Bacille Calmette-Guerin (BCG). BCG prevents some forms of TB but not pulmonary TB, which accounts for the majority of infections and deaths.
The new GSK vaccine candidate being developed under the agreement with Aeras is designed to be used in addition to BCG.
It contains GSK’s proprietary antigen M72 and the adjuvant AS01E, which includes an ingredient licensed from Antigenics, a unit of Agenus. Adjuvants are substances that are added to vaccines to increase their effectiveness.
Aeras and GSK will each provide resources to run the clinical trial in healthy adults aged between 18 and 50 years. The study is scheduled to begin in 2013, pending approvals from authorities.
United States-based Aeras is working on a number of other experimental TB vaccines with different partners, including one developed by scientists at the University of Oxford and another that is a collaboration with Johnson & Johnson unit Crucell.
Reporting by Ben Hirschler; Editing by Hans-Juergen Peters