New Nature Study Analyzes Temperature-Stable Tuberculosis Vaccine

In a recent NIH press release, the organization announced a new study published in Nature Communications analyzing the safety and immunogenicity of a new temperature-stable tuberculosis (TB) vaccine. According to the NIH, the study — posted on March 6, 2023 — is based on phase 1 clinical trial results.

The trial, supported by the National Institute of Allergy and Infectious Diseases (NIAID), recruited 48 patients who met exclusionary criteria for six months. Although 93 participants were screened, many patients were excluded from the study due to concurrent medical conditions, poor health, and abnormal lab results.

The trial ran from October 29, 2018, to June 15, 2020, with patients divided into the control and experimental group at a one-to-one ratio. The control group received an injection of non-thermostable ID9 and liquid GLA-SE, combined from two separate vials before injection.

The experimental group received a single dose of the new vaccine, ID93+GLA-SE. The vaccine was initially developed by Christopher B. Fox, PhD, and scientist at the Access to Advanced Health Institute.

According to the NIH, the ID93+GLA-SE vaccine is a “recombinant subunit vaccine made from four proteins of Mycobacterium tuberculosis bacteria combined with GLA-SE, an immune-stimulating adjuvant. The freeze-dried formulation does not require refrigeration and is mixed with sterile water just prior to injection.”

The researchers focused on local and systemic reactogenicity, adverse events, antigen-specific antibodies (IgG), and cellular immune responses. The study concluded that the single-vial temperature-stable vaccine was as safe as the two-vial vaccine. The researchers noted that both vaccines were well tolerated and developed an immune response.

Additionally, the NIH notes, “recipients of the single-vialled thermostable vaccine had robust T-cell responses and produced higher levels of antibodies in the blood than those receiving the non-thermostable two-vial presentation.”

While this is an early-phase clinical trial, and additional research is needed before the widespread use of the single-vial vaccine, this research has many implications. As the NIH and researchers noted in the study, a thermostable vaccine would be advantageous in settings where refrigerated storage and transportation are unreliable. Additionally, it could cut down healthcare spending on storage and transport.