Table 5.
Lead candidate adjuvant formulation characteristics.
| Lead Candidate Name | GLA* (mg/ml) | 3M-052* (mg/ml) | Primary phospho lipid* (mg/ml) | PEG-ylated phospho lipid* (mg/ml) | Cholesterol* (mg/ml) | α-tocopherol* (mg/ml) | Buffer (ammonium phosphate) | pH | Particle diameter (Z-ave, nm) | Size Polydisp-ersity Index (PdI) |
|---|---|---|---|---|---|---|---|---|---|---|
| PS | 1.04 +/- 0.01 | 0.36 +/- 0.00 | 3.10 +/- 0.10 (DPPC) | 0.92 +/- 0.02 (DSPE-PEG2000) | 0.86 +/- 0.03 | 0.06 +/- 0.00 | 25 mM | 5.83 | 81.4 +/- 1.4 | 0.169 +/- 0.014 |
| PP | 1.04 +/- 0.01 | 0.39 +/- 0.01 | 3.21 +/- 0.09 (DPPC) | 0.92 +/- 0.05 (DPPE-PEG2000) | 0.90 +/- 0.04 | 0.06 +/- 0.00 | 25 mM | 5.85 | 90.8 +/- 2.8 | 0.218 +/- 0.013 |
| SS | 1.02 +/- 0.01 | 0.36 +/- 0.01 | 2.89 +/- 0.11 (DSPC) | 0.84 +/- 0.03 (DSPE-PEG2000) | 0.80 +/- 0.02 | 0.06 +/- 0.00 | 25 mM | 5.75 | 85.4 +/- 1.2 | 0.217 +/- 0.005 |
| Proof-of-concept | 0.52 +/- 0.01 | 0.19 +/- 0.00 | 6.06 +/- 0.22 | 2.00 +/- 0.12 | 1.88 +/- 0.07 | – | 25 mM | 5.76 | 67.3 +/- 1.6 | 0.217 +/- 0.008 |
*Dose amounts (µg) correspond to 0.01*concentration (i.e. 1 mg/ml GLA in the adjuvant formulation results in delivery of 10 µg of GLA after mixing with antigen/diluent and delivering 20 µl total volume to the nares).