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."
Fig. 1: Screening, enrollment, randomization, and follow-up of study participants
No comments:
Post a Comment