Table 1.
Immune responses.
| INO-4800 1.0 mg dose group |
INO-4800 2.0 mg dose group |
|||||
|---|---|---|---|---|---|---|
| Immuneassay | Overall value | Responder value | Respondersa (%) | Overall value | Responder value | Respondera (%) |
| Neutralization Week 6 GMT####Reciprocal Titer####[95% CI] (Range) | 44.4####[14.6, 134.8]####(1, 11,647) | 102.3####[37.4, 280.3]####(13, 11,647) | 14/18 (78%) | 34.9####[15.8, 77.2]####(1, 652) | 63.5####[39.6, 101.8]####(13,652) | 16/19 (84%) |
| S1+S2 Binding Antibody Week 6 GMT Reciprocal Titer####[95% CI] (Range) | 331.2####[91.2, 1203.2]####(1, 14,580) | 655.5####[255.6, 1681.0]####(20, 14,580) | 17/19 (89%) | 691.4####[217.5, 2197.2]####(1, 14,580) | 994.2####[395.3, 2500.3]####(20, 14,580) | 18/19 (95%) |
| Total Seroconversion (Response in S1+S2 or Neutralization) | N/A | N/A | 18/19 (95%) | N/A | N/A | 18/19 (95%) |
| IFN-gamma ELISpot Week 8####Median SFU####[95% CI] (Range) | 26.2####[10.0, 64.4]####(1, 374.4) | 45.6####[21.1, 142.2]####(16.7, 374.4) | 14/19 (74%)µ | 71.1####[32.2, 194.4]####(8.9, 615.6) | 71.1####[32.2, 194.4]####(8.9, 615.6) | 19/19 (100%)µ |
| Overall Immune Response Rate (Seroconversion or ELISpot) | N/A | N/A | 19/19 (100%) | N/A | N/A | 19/19 (100%) |
1.0 mg Dose Group excludes one subject with baseline positive NP ELISA.
a
Response criteria: Live Neutralization – Week 6 PRNT IC50 ≥ 10, or ≥4 if binding ELISA activity is seen; S1±S2 Binding – Week 6 value >1 ELISpot – Value ≥12 SFU over Week 0
µ – Responders based on Week 6 or Week 8 data.