Table 3. HPV-31 and HPV-45 antibody responses for the 3D schedule in women aged 15–25 y and the 2D schedule in girls aged 9–14 y up to month 48 (according-to-protocol month 48 immunogenicity cohort, subjects seronegative at baseline).
Antigen | Timing (months) | 3D 20/20 M0,1,6 (women 15–25 y) |
2D 20/20 M0,6 (girls 9–14 y) |
||||
---|---|---|---|---|---|---|---|
N | Seropositive, n (%) | GMT* (95% CI), EU/mL | N | Seropositive, n (%) | GMT* (95% CI), EU/mL | ||
HPV-31 | 0 | 36 | 0 (0.0) | 29.5 (29.5, 29.5) | 40 | 0 (0.0) | 29.5 (29.5, 29.5) |
7 | 36 | 36 (100) | 1201.8 (819.2, 1763.0) | 40 | 40 (100) | 1321.7 (1011.7, 1726.7) | |
12 | 36 | 35 (97.2) | 370.0 (246.4, 555.6) | 40 | 39 (97.5) | 262.4 (197.0, 349.6) | |
18 | 36 | 35 (97.2) | 270.7 (190.9, 383.8) | 40 | 34 (85.0) | 184.7 (134.8, 253.0) | |
24 | 36 | 31 (86.1) | 215.2 (145.5, 318.3) | 40 | 35 (87.5) | 166.7 (122.8, 226.3) | |
36 | 36 | 33 (91.7) | 237.5 (166.7, 338.4) | 39 | 35 (89.7) | 173.7 (126.7, 238.1) | |
48 | 36 | 32 (88.9) | 241.7 (166.7, 350.3) | 40 | 37 (92.5) | 195.5 (144.8, 263.9) | |
HPV-45 | 0 | 38 | 0 (0.0) | 29.5 (29.5, 29.5) | 37 | 0 (0.0) | 29.5 (29.5, 29.5) |
7 | 38 | 38 (100) | 928.4 (652.0, 1322.0) | 37 | 37 (100) | 1574.5 (1156.8, 2142.8) | |
12 | 38 | 37 (97.4) | 306.1 (207.9, 450.7) | 37 | 35 (94.6) | 305.7 (209.3, 446.4) | |
18 | 38 | 33 (86.8) | 204.3 (140.0, 298.2) | 37 | 32 (86.5) | 191.6 (133.0, 275.8) | |
24 | 38 | 33 (86.8) | 178.4 (124.8, 254.9) | 37 | 32 (86.5) | 176.7 (121.9, 256.3) | |
36 | 38 | 32 (84.2) | 169.3 (117.8, 243.4) | 36 | 31 (86.1) | 177.4 (124.4, 252.8) | |
48 | 38 | 30 (78.9) | 147.2 (102.0, 212.5) | 37 | 34 (91.9) | 156.6 (114.2, 214.7) |
2D, 2-dose schedule; 3D, 3-dose schedule; 20/20, 20 μg each of HPV-16 and -18 L1 virus-like particles; 95% CI, exact 95% confidence interval; EU/mL, ELISA unit per milliliter; GMT, geometric mean antibody titer; M, month; N, number of evaluable seronegative subjects in the according-to-protocol month 48 immunogenicity cohort; n (%), number (percentage) of seropositive subjects with antibody titer greater than or equal to the cut-off value (≥59 EU/mL for HPV-31 and HPV-45). *Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation.