Fig. 10From: The thermostability of the RTS,S/AS01 malaria vaccine can be increased by co-lyophilizing RTS,S and AS01Evaluation of the immunogenic properties of CL-vac after storage. CL-vac was stored at 37 °C for 6 months or at 4 or 30 °C for up to 12 months. In addition, CL-vac was stored for 12 months at 30 °C followed by 1 month at 45 °C (heat excursion). After reconstitution of the vaccine, mice were immunized three times intramuscularly and the induced cellular responses were evaluated 7 days after the third immunization by intracellular cytokine staining, measuring the percentage of CSP- and HBsAg-specific CD4 + T cells expressing IFNγ and/or IL-2 and/or TNF. Immunization with the RTS,S/AS01 two-vial formulation was used as control. One dot represents one mouse. The black bars are geomeans with 95% CIs. The statistical analysis aimed to demonstrate equivalence between the reference (two-vial formulation) and the other stability conditions in a sequential manner, starting with CL-vac 6 months 37 °C, then CL-vac 12 months 4 °C, CL-vac 12 months 30 °C, and CL-vac 12 months 30 °C + 1 month 45 °C. Full equivalence was found for CSP- and HBsAg-specific cellular responsesBack to article page