The Seattle-based nonprofit biotech research institute Access to Advanced Health Institute (AAHI) announced the results of Phase 1 clinical trial demonstrating that a new vaccine candidate against tuberculosis (TB) that combines several proteins from Mycobacterium tuberculosis with a proprietary immune-stimulating adjuvant in a freeze-dried formulation that can be stored at higher temperatures (nearly 100 degrees Fahrenheit or 37.7 degrees Celsius) for severe tuberculosis

According to a recent press release, a single vial of this freeze-dried TB vaccine candidate produced a stronger immune response than administration of the same vaccine using separate vials of antigen and liquid adjuvant formulation.

The trial evaluated the safety, tolerability, and immunogenicity of the thermostable, freeze-dried single-vial vaccine candidate compared to the previous version of the vaccine, which came in a two-vial packing and had demonstrated promising safety and immunogenicity in Phase 2 clinical testing, according to AAHI, who noted that the single-vial TB vaccine candidate represents significant progress in global efforts to combat TB.

Commenting on the trial findings, Dr Christopher Fox, Senior Vice President of Formulations and Principal Investigator of the contract awarded by the National Institutes of Health (NIH) that funded the trial, said, “Adjuvanted subunit vaccines have re-energised the field of TB vaccine development.”

“This study represents the first temperature-stable adjuvant-containing subunit TB vaccine candidate to be evaluated in the clinic,” he added.

“An effective thermostable TB vaccine would not only be better suited to reach areas of the world most burdened by the disease, but it would also mitigate costs and reduce wastage associated with more stringent cold-chain storage requirements,” Dr Fox said.

Stressing that more studies will be needed to scale up manufacturing and establish that the vaccine candidate will protect populations in low-resource communities most burdened by TB, including Southeast Asia and Sub-Saharan Africa, AAHI said that these areas struggle to maintain even simple refrigeration for vaccine transport and storage and by reducing the need for cold chain, AAHI’s TB vaccine candidate may significantly advance the global fight against TB.

“Equitable access to vaccines has been significantly impeded by cold-chain requirements and, as observed with COVID19, no one is safe until everyone is safe,” Chief Executive Officer at AAHI Dr Corey Casper, explained.

“The development of a safe and immunogenic temperature-stable TB vaccine is a major achievement towards our mission of bringing vaccines to people who most need them, regardless of geography,” he added.