A vaccine can be developed and used, but if it gets damaged during transport, “it does no good.”
That assessment comes from Steven G. Reed, president, founder and chief scientific officer of Infectious Disease Research Institute (IDRI), who announced on Wednesday that his company had been awarded a National Institute of Allergy and Infectious Diseases contract that could be worth nearly $12 million to develop a thermostable tuberculosis (TB) vaccine.
"Too often in vaccine development, the question of deliverability isn't asked until it's too late in the process," Dr. Christopher Fox, director of IDRI's Adjuvant Formulations Program who will lead the project, said. "We are nimble enough that we can get in the door with a new process early in the development cycle that addresses this issue, including the added challenge that comes with lyophilizing vaccines containing complex multi-component formulations."
IDRI is attempting to create a way to freeze-dry (lyophilize) two of its current TB vaccine projects, ID93 and GLA-SE, thereby making it easier and less risky to transport. By doing this, the shelf life of the vaccines may increase and it may possibly allow vaccines to be shipped without the necessity of staying cold throughout the journey.
One of IDRI's partners in the contract is Lyophilization Technology Inc., a company that specializes in freeze-drying health care products.
"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," Fox said.
The findings of those studies were published in the Journal of Controlled Release earlier this year.
"The ultimate test will be completing a Phase 1 clinical trial that shows safety and immunogenicity of a lyophilized adjuvanted vaccine,” Fox said.