IDRI Receives NIH Grant To Develop Thermostable TB Vaccine
The Seattle-based Infectious Disease Research Institute (IDRI) announced that it has received a grant from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to develop a thermostable tuberculosis vaccine designed to be resistant to damage from temperature changes.
The NIH contract stipulates a base award of $3.6 million with up to $11.9 million in additional funds upon achievement of certain milestones. The grant will support a team of IDRI scientists led by Dr. Christopher Fox to develop, manufacture, and investigate a thermostable lyophilized formulation of its vaccine candidate for tuberculosis. The Institute has previously received a $3.4 million grant extension from the Bill & Melinda Gates Foundation to support its drug discovery program for TB.
TB bacteria infects approximately a third of the worldwide population. Last year alone, around 9 million people developed active cases of tuberculosis. Developing a vaccine against tuberculosis that can be transported outside of the cold chain, or temperate-controlled supply chain, leapfrogs what Doctors Without Borders has determined to be one of the biggest barriers to effective vaccination.
“You can have the best vaccine in the world, but if it's damaged during the delivery process, it does no good. Thermostable vaccines could have great economic and health benefits for the recipients by ensuring that vaccines are intact and effective when delivered,” said Dr. Steven G. Reed, IDRI President, Founder and CSO.
IDRI is currently developing its next-generation, rationally designed TB vaccine that comprises an antigen and an adjuvant contained separately before administration. The contract will help IDRI develop the first clinical emulsion-based adjuvant formulation to be lyophilized or freeze dried, which helps extend its shelf life.
“To provide the foundation for our product development plan for this contract, IDRI conducted successful preliminary studies showing that ID93 and GLA-SE can be co-lyophilized to generate a single-vial dried vaccine that maintains protective biological activity even after exposure to 122 degrees Fahrenheit for one month… To our knowledge, no one has demonstrated being able to lyophilize an oil-in-water emulsion-based adjuvant that maintains the same physicochemical properties after reconstitution as it had before lyophilization, so this will be a new step in creating temperature stable vaccines for the future,” said Dr. Fox. He added that the resulting lyophilized adjuvanted vaccine will be tested in a Phase 1 trial for safety and immunogenicity.
IDRI recently announced that it has licensed its Glycopyranosyl Lipid Adjuvant (GLA) vaccine adjuvant formulation to vaccine biotech firm, Immune Design.