Temperature-Stable Experimental TB Vaccine Enters Clinical Testing

Vaccinations have begun in a phase 1 human clinical trial testing a freeze-dried, temperature-stable formulation of an experimental tuberculosis (TB) vaccine candidate. The trial is being conducted at the Saint Louis University School of Medicine Center for Vaccine Development and will enroll as many as 48 healthy adult volunteers ages 18 to 55. The experimental vaccine, called ID93, was developed by scientists at the Infectious Disease Research Institute in Seattle; NIAID is supporting the trial through a contract to IDRI.

ID93 is a recombinant vaccine candidate made from four proteins of Mycobacterium tuberculosis (the bacterium that causes TB). Many vaccines require a temperature-controlled system during transport, which can be costly and logistically challenging. Freeze-dried powder vaccines can be distributed at a cheaper cost to remote, low-resource settings. The powder formulations are mixed with sterile water for administering with a needle and syringe. 

Investigators are examining if a powder formulation combining ID93 and the adjuvant GLA-SE (an immune response-stimulating protein) in a single vial, reconstituted with sterile water, is as effective at inducing an immune response in participants as the previously tested two-vial combination of powdered ID93 and liquid GLA-SE.

“Tuberculosis remains the leading infectious cause of death worldwide and a highly effective vaccine would be a crucial tool in ending this pandemic,” said NIAID director Dr. Anthony Fauci. “A vaccine that did not require a cold chain could be much more easily distributed to communities in need.”