Fig. 11From: 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 antibody responses were evaluated 2 weeks after the third immunization by ELISA. 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 anti-HBsAg antibody responses. For the anti-CSP (R32LR) responses, equivalence to the two-vial formulation was found for CL-vac 6 months 37 °C, but not for CL-vac 12 months 4 °C, and consecutively not for the others (see “Results”)Back to article page