Table 2.
Immunogenicity summary of RVNA titers and GMTs on D14, 28, and 42 (per protocol analysis set).
| Low-dose PVRV-NG2 (n = 72) | Medium-dose PVRV-NG2 (n = 75) | High-dose PVRV-NG2 (n = 71) | PVRV-NG (n = 35) | HDCV (n = 34) | |
|---|---|---|---|---|---|
| Pre-dose 1 (D0) | |||||
| Participants with available RVNA titers, n | 72 | 75 | 71 | 35 | 34 |
| RVNA titer ≥ 0.5 IU/mL, n (%) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| 95% CI | 0, 5.0 | 0, 4.8 | 0, 5.1 | 0, 10.0 | 0, 10.3 |
| Titers, geometric mean (95% CI) | 0.10 (0.10, 0.10) | 0.10 (NC) | 0.10 (0.10, 0.10) | 0.10 (0.10, 0.10) | 0.10 (NC) |
| D14 (7 days post Dose 3) | |||||
| Participants with available RVNA titers, n | 72 | 75 | 71 | 35 | 34 |
| RVNA titer ≥ 0.5 IU/mL, n (%) | 54 (75.0) | 61 (81.3) | 64 (90.1) | 28 (80.0) | 30 (88.2) |
| 95% CI | 63.4, 84.5 | 70.7, 89.4 | 80.7, 95.9 | 63.1, 91.6 | 72.5, 96.7 |
| Titers, geometric mean (95% CI) | 1.28 (0.94, 1.73) | 1.79 (1.33, 2.41) | 2.52 (1.93, 3.28) | 1.38 (0.94, 2.05) | 1.56 (1.1, 2.3) |
| D28 (14 days post Dose 4) | |||||
| Participants with available RVNA titers , n | 66 | 73 | 68 | 29 | 33 |
| RVNA titer ≥ 0.5 IU/mL, n (%) | 62 (93.9) | 70 (95.9) | 68 (100) | 25 (86.2) | 33 (100) |
| 95% CI | 85.2, 98.3 | 88.5, 99.1 | 94.7, 100 | 68.3, 96.1 | 89.4, 100 |
| Titers, geometric mean (95% CI) | 3.22 (2.48, 4.17) | 4.64 (3.53, 6.10) | 6.81 (5.52, 8.39) | 3.04 (1.86, 4.95) | 4.86 (3.56, 6.65) |
| D42 (14 days post Dose 5) | |||||
| Participants with available RVNA titers , n | 69 | 72 | 65 | 30 | 331 |
| RVNA titer ≥ 0.5 IU/mL, n (%) | 69 (100) | 71 (98.6) | 65 (100) | 29 (96.7) | 31 (100) |
| 95% CI | 94.8, 100 | 92.5, 100 | 94.5, 100 | 82.8, 99.9 | 88.8, 100 |
| Titers, geometric mean (95% CI) | 8.14 (6.60, 10.0) | 9.68 (7.50, 12.5) | 15.6 (12.7, 19.1) | 6.98 (4.69, 10.4) | 8.99 (6.48, 12.5) |
D, day; n, number of participants fulfilling criteria of the specified item; RVNA, Rabies virus neutralizing antibody.