Will begin phase II trials in Kenya, India and South Africa
GSK has joined up with not-for-profit biotech Aeras to advance an investigational tuberculosis (TB) vaccine through clinical trials.
The partners will each provide resources to run a multi-centre proof of concept clinical study of the vaccine candidate, which contains GSK’s proprietary M72 antigen and AS01E adjuvant, in healthy adults between 18 and 50 years of age.
This phase IIb trial is scheduled to begin in Kenya, India and South Africa next year pending approvals from authorities.
The vaccine has already demonstrated promising results in early stage clinical trials, achieving an acceptable safety as well as an immune response.
TB kills 1.4 million people annually, despite the widespread use of the currently available TB vaccine, Bacille Calmette-Guèrin (BCG), which is unable to prevent pulmonary TB despite preventing some forms of the disease in infants.
As such, new vaccines are urgently needed, and GSK/ Aeras’ candidate is intended to be use in addition to BCG.
“We will never reverse the spread of the global TB epidemic without new vaccines as part of the solution,” said Jim Connolly, president and CEO of Aeras.
“Working in partnership with GSK – sharing resources, capabilities and know-how – affords us the opportunity to conduct this pivotal, multi-country proof of concept trial, getting us that much closer to potentially one day having a TB vaccine that could protect adolescents and adults from one of the world’s deadliest infectious diseases.”
GSK’s vaccines division received another boost this week when it was announced its Synflorix vaccine would be used during Pakistan’s national immunisation programme to protect against pneumococcal disease.
The company is providing the vaccine at a discount of 90 per cent through the non-profit Global Alliance for Vaccines and Immunization’s (GAVI) advanced market commitment.