Tuesday, March 07, 2023

New tuberculosis vaccine candidate is thermostable and can be stored at 37C

Good news!

"A new freeze-dried tuberculosis vaccine has yielded encouraging results in a Phase 1 clinical trial, raising hopes that the vaccine—which can be stored at 37C degrees (100F) for months—could significantly expand prevention efforts.
The small trial [very small trial?] showed the temperature-stable, Access to Advanced Health Institute vaccine was safe and led to measurable immune responses ..." (Source)

From the abstract:
"Adjuvant-containing subunit vaccines represent a promising approach for protection against tuberculosis (TB), but current candidates require refrigerated storage. Here we present results from a randomized, double-blinded Phase 1 clinical trial (NCT03722472) evaluating the safety, tolerability, and immunogenicity of a thermostable lyophilized single-vial presentation of the ID93 + GLA-SE vaccine candidate compared to the non-thermostable two-vial vaccine presentation in healthy adults. Participants were monitored for primary, secondary, and exploratory endpoints following intramuscular administration of two vaccine doses 56 days apart. ... Both vaccine presentations are safe and well tolerated and elicit robust antigen-specific serum antibody and Th1-type cellular immune responses. Compared to the non-thermostable presentation, the thermostable vaccine formulation generates greater serum antibody responses (p < 0.05) and more antibody-secreting cells (p < 0.05). In this work, we show the thermostable ID93 + GLA-SE vaccine candidate is safe and immunogenic in healthy adults."

Safety and immunogenicity of a thermostable ID93 + GLA-SE tuberculosis vaccine candidate in healthy adults | Nature Communications

Fig. 1: Screening, enrollment, randomization, and follow-up of study participants


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