The Infectious Disease Research Institute (IDRI) and Wellcome Trust announced that they have started the Phase 2a trial of a tuberculosis (TB) vaccine candidate in South Africa.
This vaccine shows promise in treating and preventing TB in animal models involved in the studies.
“In the current study we are evaluating the safety and immunogenicity of the vaccine in subjects who have undergone a full course of antibiotic treatment," Rhea Coler, Ph.D., vice president of preclinical development for IDRI, said. "This study paves the way for the fficacy trial in which we propose to test the hypothesis based on proof of concept preclinical data that the candidate vaccine will reduce the recurrence of TB after a patient has been successfully treated for active TB.”
If positive result comes from the current ongoing trial, it will be moved to the efficacy-testing phase of clinical development.
TB is often contracted again, which is harmful to TB control.
“Since active TB is slow to respond completely to therapy, prescribed medications must be taken every day for a long time," Coler said. "This may be at least six months and, sometimes, a year or more. The biggest danger in TB treatment is that the patient will not take antibiotics on schedule. This gives the bacteria the opportunity to develop resistance to the drugs, rebound or recur, and become much more difficult to treat. It is crucial to take all of your drugs as instructed. The hope of launching an effective vaccine that prevents recurrence of TB disease would have major positive breakthroughs for global TB control.”
The Wellcome Trust has awarded IDRI $5.8 million to conduct the study, but the IDRI is currently seeking additional funding to execute this TB efficacy trial.