November 8th, 2022-Promising clinical efficacy results have generated considerable enthusiasm for the potential impact of adjuvant-containing subunit tuberculosis vaccines. LTI was engaged in the development, process engineering, and preparation of clinical material of the tuberculosis vaccine candidate ID93 / GLA-SE. The tuberculosis vaccine has reached successful Phase 2 clinical testing. This study represents the first report on the successful lyophilization of a thermostable subunit vaccine candidate containing an emulsion-based adjuvant.
This development is presented in Frontiers In Drug Delivery. The work is in collaboration with Access to Advanced Health Institute (AAHI; formerly Infectious Disease Research Institute), Seattle, Department of Global Health, University of Washington, Seattle, and the Department of Pharmaceutical Chemistry, Obafemi Awolowo University, Ile-Ife, Nigeria.
The publication details the lyophilization process development and preparation of clinical study material. Long-term stability of the thermostable tuberculosis vaccine formulation was demonstrated with 24 months stability when stored at 5°C. The cGMP lyophilized ID93 / GLA-SE also maintained stability for 3 months when stored at 37°C. This work represents the first advancement of a thermostable adjuvant-containing subunit tuberculosis vaccine to clinical study readiness.
Publication of the article “Lyophilization Process Engineering and Thermostability of ID93 + GLA-SE, a Single-Vial Adjuvanted Subunit Tuberculosis Vaccine Candidate for Use in Clinical Studies” in Frontiers In Drug Delivery, Vaccine Delivery section is an open access publication accessible to readers anywhere in the world. To view the online publication, please CLICK HERE: