Table 5.
Number of patients with determined virus neutralization results and achieving complete neutralization at 1:5 dilution in RFFIT (per-protocol analysis set).
| Participants with complete neutralizationa | 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) |
|---|---|---|---|---|---|
| D14 (7 days post Dose 3) | |||||
| Participants with determined neutralization result (N) | 58 | 70 | 66 | 31 | 29 |
| Participants with complete neutralization at 1:5 dilution, n (%) 95% CI | 57 (98.3) | 67 (95.7) | 66 (100) | 29 (93.5) | 29 (100) |
| 90.8, 100 | 88.0, 99.1 | 94.6, 100 | 78.6, 99.2 | 88.1, 100 | |
| D28 (14 days post Dose 4) | |||||
| Participants with determined neutralization result (N) | 64 | 71 | 69 | 32 | 31 |
| Participants with complete neutralization at 1:5 dilution, n (%) 95% CI | 64 (100) | 70 (98.6) | 69 (100) | 32 (100) | 31 (100) |
| 94.4, 100 | 92.4, 100 | 94.8, 100 | 89.1, 100 | 88.8, 100 | |
| D42 (14 days post Dose 5) | |||||
| Participants with determined neutralization result (N) | 67 | 70 | 64 | 31 | 31 |
| Participants with complete neutralization at 1/5 dilution, n (%) 95% CI | 67 (100) | 69 (98.6) | 64 (100) | 31 (100) | 31 (100) |
| 94.6, 100 | 92.3, 100 | 94.4, 100 | 88.8, 100 | 88.8, 100 | |
| Month 7 (6 months post Dose 5) | |||||
| Participants with determined neutralization result (N) | 61 | 65 | 65 | 25 | 30 |
| Participants with complete neutralization at 1/5 dilution, n (%) 95% CI | 58 (95.1) | 63 (96.9) | 65 (100) | 23 (92.0) | 29 (96.7) |
| 86.3, 99.0 | 89.3, 99.6 | 94.5, 100 | 74.0, 99.0 | 82.8, 99.9 | |
aAdvisory Committee on Immunization Practice (US ACIP) definition of adequate immune response; patients with an undetermined neutralization result (e.g., inconsistent duplicates) were excluded from this analysis.
N, number of participants with available data for the relevant endpoint.