Table 2.
The median Effective Dose (ED50) and Relative Potency at release and at pre-defined post-release timepoints of two lots in a long-term stability evaluation program.
| Potency Time Point by Month | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aeras Lot #11-69f-003 | ||||||||||||||||
| Potency Metric | 0a | 4 | 7 | 13 | 18 | 24 | 36 | 39 | 42 | 45 | 48 | 51 | 54 | 60 | 72 | 84 |
| ED50b | 4.82 | 4.78 | 4.73 | 5.75 | 4.98 | 4.98 | 9.39 | 6.24 | 5.78 | 4.82 | 3.45 | 4.03 | 3.15 | 2.93 | 3.1 | 7.8 |
| (95% CL)c | (3.52, 6.71) | (2.38, 9.13) | (3.77, 6.02) | (4.3, 7.59) | (3.97, 6.37) | (3.97, 6.37) | (6.17, 14.36) | (4.67, 8.4) | N/A | (3.49, 6.59) | (2.67, 4.4) | (3.14, 5.17) | (2.51, 4.06) | N/A | (2.41, 3.89) | (5.98, 10.29) |
| RP | – | 1.01 | 1 | 0.84 | 0.94 | 0.94 | 0.51 | 0.77 | 0.81 | 1 | 1.39 | 1.18 | 1.49 | 1.74 | 1.55 | 0.61 |
| (95% CL) | – | (0.64, 1.58) | (0.67, 1.47) | (0.55, 1.26) | (0.64, 1.4) | (0.64, 1.4) | (0.31, 0.85) | (0.5, 1.16) | (0.5, 1.33) | (0.65, 1.54) | (0.93, 2.07) | (0.79, 1.75) | (1.01, 2.21) | (1.18, 2.56) | (1.05, 2.30) | (0.41, 0.91) |
| WRAIR Lot #1975 | ||||||||||||||||
| Potency | ||||||||||||||||
| Metric | 0 | 3a | 6 | 9 | 12 | 18 | 24 | 36 | ||||||||
| ED50 | 4.05 | 3.83 | 3.24 | 3.24 | 7.05 | 4.24 | 2.96 | 8.59 | ||||||||
| (95% CL) | N/A | (2.92, 4.99) | N/A | N/A | (5.77, 8.61) | (3.30, 5.49) | (2.23, 3.98) | (4.03, 17.36) | ||||||||
| RP | – | – | 1.073 | 1.073 | 0.545 | 0.9 | 1.29 | 0.44 | ||||||||
| (95% CL) | – | – | (0.78, 1.47) | (0.78, 1.47) | (0.40, 0.75) | (0.64, 1.27) | (0.89, 1.88) | (0.29, 0.66) | ||||||||
a
Potency at “lot release” based on which relative potency is calculated for subsequent time points.
b
The theoretical dose in µg that would produce seroconversion in 50% of the mice.
c
95% Confidence Limits.