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The thermostability of the RTS,S/AS01 malaria vaccine can be increased by co-lyophilizing RTS,S and AS01
Juliette Fortpied1, Sylvie Collignon2, Nicolas Moniotte2
1GSK, Rue de l'Institut 89, 1330, Rixensart, Belgium. Juliette.x.fortpied@gsk.com.
Malaria Journal
|June 10, 2020
Summary
Co-lyophilization significantly enhances the thermostability of the RTS,S/AS01 malaria vaccine, making it suitable for high-temperature storage. This innovation addresses a key challenge in vaccine distribution, particularly in regions lacking robust cold chains.
Area of Science:
- Vaccinology
- Pharmaceutical Sciences
- Biotechnology
Background:
- Thermostable vaccine development is crucial for global health, especially in high-temperature regions lacking cold chain infrastructure.
- The malaria candidate vaccine RTS,S/AS01 requires strict 2-8°C storage due to AS01 component instability.
- Current storage limitations hinder vaccine accessibility and efficacy in resource-limited settings.
Purpose of the Study:
- To develop a cost-effective method for increasing the thermostability of the RTS,S/AS01 malaria vaccine.
- To assess the feasibility of co-lyophilization as a strategy to improve vaccine heat resistance.
- To evaluate the physico-chemical characteristics and immunogenicity of the stabilized vaccine.
Main Methods:
- Co-lyophilization of RTS,S antigen and AS01 adjuvant in a solution containing sucrose, potassium phosphate, and polysorbate 80.
- Characterization of the resulting solid product (CL-vac) for visual appearance, physico-chemical properties, structural integrity, and immunogenicity.
- Stability assessment of CL-vac under various accelerated storage conditions (e.g., 1 year at 30°C, 6 months at 37°C, 1 month at 45°C).
Main Results:
- The co-lyophilized vaccine (CL-vac) exhibited acceptable physico-chemical characteristics and maintained the structural integrity of RTS,S and AS01.
- CL-vac demonstrated significant thermostability, remaining stable for up to 1 year at 30°C and withstanding a 1-month heat excursion at 45°C.
- Immunogenicity studies in mice confirmed the equivalence of CL-vac to the original RTS,S/AS01 vaccine after storage.
Conclusions:
- Co-lyophilization is a promising and cost-effective approach to enhance the thermostability of the RTS,S/AS01 malaria vaccine.
- The developed CL-vac formulation offers a viable solution for improved vaccine storage and distribution, particularly in challenging environments.
- This strategy could significantly improve malaria vaccine accessibility and impact in endemic regions.
