Statens Serum Institut and Aeras said on Tuesday that Phase II of the first randomized, controlled tuberculosis vaccine trial to study the prevention of Mycobacterium tuberculosis has begun.
The vaccine, H4+IC21, will test the safety, immunogenicity and its ability to prevent infection.
"For the first time in a TB vaccine trial, we will be testing for infection by Mtb, rather than waiting to measure the occurrence of clinical disease, which is more expensive and requires much larger studies," Aeras President and CEO Thomas Evans said. "This will enable us to obtain results much more quickly and with fewer subjects, and the data we generate will ensure that the entire field of TB vaccine R&D progresses in a more informed and streamlined way."
The study will enroll 990 adolescents in Western Cape Province, South Africa, and be conducted by the South African Tuberculosis Vaccine Initiative. The trial is randomized, placebo-controlled and partially blinded.
The current TB vaccine, Bacille Calmette-Guerin, is one of the most used vaccines in the world. The vaccine prevents some forms of the illness in children, but its widespread use in infants has failed to control the disease. Studies indicate the vaccine is effective in preventing infection, but it has not undergone a randomized, controlled, prospective trial.
"Right now, we do not have a reliable way to prevent people who are exposed to Mtb from becoming infected, and one out of 10 people who become infected will develop active TB disease at some point in their life," Mark Hatherill, SATVI's interim director, said. "Preventing new infections by vaccination, and interrupting the cycle of transmission, would make a tremendous impact on the TB epidemic."