Adeagbo, B.A., et al. Lyophilization Strategy Enhances the Thermostability and Field-Based Stability of Conjugated and Comixed Subunit Liposomal Adjuvant-containing Tuberculosis Vaccine Formulation (ID93 + GLA-LSQ).

Adeagbo, B.A., et al. Lyophilization Strategy Enhances the Thermostability and Field-Based Stability of Conjugated and Comixed Subunit Liposomal Adjuvant-containing Tuberculosis Vaccine Formulation (ID93 + GLA-LSQ).

Mol Pharm. 2025 Apr 7, 22(4):2306-2315. PMID: 40105111

• The study investigates the stability of a tuberculosis vaccine formulation, ID93 + GLA-LSQ, enhanced through lyophilization with the inclusion of 10% Trehalose as a cryoprotectant and bulking agent. This strategy aims to create a thermostable single-vial vaccine formulation suitable for non-refrigerated storage conditions. The research assessed the physical and biological stability of both co-mixed (CoVL) and conjugated (ConjVL) formulations over a period of three months in a laboratory setting and nine months at ambient temperatures across five health centers in Nigeria.  

• The stability assessment of the adjuvants, specifically GLA and QS-21, revealed that their degradation remained within acceptable limits after storage. The study reported a reduction in GLA and QS-21 content of less than 20% for both formulations across various storage sites after nine months at ambient temperature. Results indicated that both formulations maintained their physical integrity, liposomal structure, and antigen stability, with limited chemical degradation observed, particularly noting that ConjVL exhibited slightly better retention of GLA compared to CoVL, suggesting that the conjugated formulation may provide a more stable environment for the adjuvant over the storage period. The findings highlight the promising potential of these formulations for real-world applications without strict refrigeration requirements. 

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