A lot of people think tuberculosis is a thing of the past, but it remains one of the most deadly diseases in the world. Now the Seattle-based Infectious Disease Research Institute is getting ready to take it on with a new vaccine being prepped for clinical trials.
IDRI said today it has formed a partnership with another nonprofit, Rockville, MD-based Aeras, to test a new vaccine candidate for tuberculosis. IDRI and Aeras said they expect to start an initial study to assess the vaccine’s safety in healthy volunteers later this year.
There already is an available TB vaccine that was developed 90 years ago, but it didn’t stop an estimated 1.4 million people from dying of the infectious disease in 2010. As many people infected with HIV in the developing world end up getting TB, and as multi-drug resistant forms of bacterial infection have continued to evolve, it has created new urgency for scientists to come up with an effective TB vaccine. Both IDRI and Aeras are funded by the Bill & Melinda Gates Foundation, and have a lot of experience in the fight against global infectious disease. Aeras has invented or is supporting the development of six TB vaccine candidates, five of which are in clinical trials today, while IDRI has invented the key intellectual property in this newest candidate.
“Given Aeras’ focus and breadth of experience in supporting the clinical development of tuberculosis vaccines, we believe this collaboration will speed the development of this promising new vaccine,” said Steve Reed, IDRI’s founder and chief scientific officer, in a statement.
The new vaccine candidate, dubbed ID93/GLA-SE, uses a genetically engineered fusion protein designed by IDRI to alert the immune system to a marker on TB bacteria, combined with an immune-boosting compound known as an adjuvant. This adjuvant, GLA, is a synthetic compound designed to be more potent than past adjuvants made from natural products. Scientists are hopeful it can be manufactured consistently and cheaply at the kind of large scales that would be necessary for an effective TB vaccination campaign. The adjuvant has already been used in a wide array of experiments, including some for Seattle-based Immune Design, which is seeking to develop commercial immune-boosting therapies for Herpes Simplex Virus 2 (genital herpes) and cancer.
IDRI said in today’s statement that the vaccine candidate has shown “an acceptable safety profile” in animal tests and substantial protection from the TB bug. The vaccine appeared effective in animals that had previously gotten the existing vaccine, BCG, to prime their immune systems, and among animals that hadn’t gotten the old vaccine.
Today’s statement didn’t name a commercial partner, or discuss the financial resources needed to push the vaccine through this phase of clinical trials. But IDRI has conducted all of the preclinical development of the vaccine so far, with about $35 million of support from the National Instiutes of Health, according to Erik Iverson, IDRI’s executive vice president of business development. Most of the funding for the clinical trials is coming from the Gates Foundation and the Paul G. Allen Family Foundation, Iverson said.
Aeras and IDRI said in today’s statement they are committed to make sure that new vaccines they develop “will be accessible and affordable to those who need them most in developing countries.”
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