Table 7.
Month 7 anti-HPV geometric mean titers in women, 16–26 years of age who completed the 3-dose 9vHPV vaccine regimen in study 001.
|
Per protocol immunogenicity population |
Day 1 seropositive and PCR-negative |
|||
|---|---|---|---|---|
|
Assay time point |
n | GMT (95% CI) | n | GMT (95% CI) |
| HPV 6 | ||||
| Day 1 | 3993 | <16 (<16, <16) | 917 | 108.1 (102.2, 114.3) |
| Month 3 | 788 | 734.0 (692.8, 777.7) | 188 | 2384.0 (1982.9, 2866.1) |
| Month 7 | 3993 | 893.1 (871.7, 915.1) | 752 | 1874.8 (1737.6, 2022.8) |
| Month 12 | 800 | 330.6 (312.2, 350.1) | 213 | 951.9 (807.3, 1122.3) |
| Month 24 | 715 | 208.6 (195.5, 222.7) | 182 | 634.3 (529.6, 759.8) |
| Month 36 | 685 | 163.9 (153.0, 175.6) | 155 | 462.9 (382.5, 560.2) |
| Month 42 | 692 | 147.2 (137.3, 157.8) | 163 | 444.1 (369.2, 534.3) |
| HPV 11 | ||||
| Day 1 | 3995 | <6 (<6, <6) | 208 | 44.6 (39.2, 50.8) |
| Month 3 | 790 | 529.1 (499.7, 560.1) | 44 | 1666.4 (1229.9, 2257.9) |
| Month 7 | 3995 | 666.3 (649.6, 683.4) | 175 | 1050.2 (914.9, 1205.6) |
| Month 12 | 810 | 212.4 (200.1, 225.6) | 49 | 609.9 (465.7, 798.9) |
| Month 24 | 763 | 123.3 (115.8, 131.2) | 40 | 360.7 (264.9, 491.0) |
| Month 36 | 690 | 89.6 (83.3, 96.3) | 35 | 214.4 (149.4, 307.7) |
| Month 42 | 696 | 84.9 (79.0, 91.3) | 34 | 201.9, (140.6, 289.8) |
| HPV 16 | ||||
| Day 1 | 4032 | <12 (<12, <12) | 564 | 126.6 (115.1, 139.3) |
| Month 3 | 794 | 2435.8 (2303.5, 2575.6) | 104 | 7064.1 (5775.9, 8639.7) |
| Month 7 | 4032 | 3131.1 (3057.1, 3206.9) | 458 | 5149.6 (4752.9, 5579.5) |
| Month 12 | 819 | 1041.7 (979.9, 1107.4) | 134 | 3079.9 (2582.1, 3673.6) |
| Month 24 | 778 | 520.7 (484.7, 559.4) | 98 | 1824.4 (1436.6, 2316.9) |
| Month 36 | 695 | 386.5 (356.3, 419.4) | 82 | 1228.6 (939.5, 1606.6) |
| Month 42 | 709 | 346.8 (319.3, 376.7) | 90 | 1186.7 (934.8, 1506.4) |
| HPV 18 | ||||
| Day 1 | 4539 | <8 (<8, <8) | 296 | 83.0 (74.3, 92.8) |
| Month 3 | 908 | 470.8 (442.8, 500.7) | 58 | 1920.1 (1464.2, 2517.9) |
| Month 7 | 4539 | 804.6 (782.7, 827.1) | 241 | 1883.4 (1670.6, 2123.4) |
| Month 12 | 929 | 198.6 (184.9, 213.4) | 72 | 1012.7 (773.7, 1325.6) |
| Month 24 | 886 | 86.0 (79.0, 93.6) | 52 | 537.2 (390.1, 739.8) |
| Month 36 | 789 | 78.5 (71.9, 85.6) | 48 | 397.0 (285.8, 551.5) |
| Month 42 | 806 | 70.8 (64.8, 77.3) | 47 | 374.9 (268.6, 523.2) |
| HPV 31 | ||||
| Day 1 | 4466 | <4 (<4, <4) | 373 | 38.7 (35.0, 42.6) |
| Month 3 | 881 | 437.6 (406.7, 470.8) | 83 | 825.6 (609.4, 1118.4) |
| Month 7 | 4466 | 658.4 (636.7, 680.9) | 295 | 952.8 (831.5, 1091.8) |
| Month 12 | 909 | 196.5 (183.5, 210.4) | 90 | 452.2 (340.3, 600.8) |
| Month 24 | 863 | 101.9 (94.9, 109.5) | 71 | 242.0 (174.5, 335.6) |
| Month 36 | 772 | 72.7 (67.5, 78.4) | 62 | 182.1 (128.4, 258.4) |
| Month 42 | 783 | 70.4 (65.3, 75.9) | 68 | 163.7 (119.9, 223.4) |
| HPV 33 | ||||
| Day 1 | 4702 | <4 (<4, <4) | 248 | 24.9 (22.1, 28.0) |
| Month 3 | 937 | 287.8 (272.9, 303.5) | 50 | 647.0 (459.2, 911.4) |
| Month 7 | 4702 | 415.9 (405.6, 426.4) | 196 | 660.4 (550.1, 792.9) |
| Month 12 | 958 | 126.2 (119.9, 132.9) | 68 | 372.9 (276.8, 502.4) |
| Month 24 | 909 | 65.3 (61.7, 69.0) | 52 | 243.3 (169.1, 349.8) |
| Month 36 | 813 | 46.8 (44.0, 49.8) | 45 | 184.0 (124.1, 272.9) |
| Month 42 | 835 | 44.3 (41.6, 47.1) | 39 | 172.6 (111.8, 266.5) |
| HPV 45 | ||||
| Day 1 | 4792 | <3 (<3, <3) | 97 | 23.7 (20.2, 27.9) |
| Month 3 | 956 | 160.4 (151.7, 169.7) | 14 | 389.1 (197.5, 766.4) |
| Month 7 | 4792 | 252.8 (246.2, 259.6) | 76 | 346.8 (244.3, 492.4) |
| Month 12 | 976 | 69.2 (65.4, 73.3) | 18 | 203.5 (105.3, 393.5) |
| Month 24 | 928 | 33.0 (31.0, 35.0) | 13 | 115.5 (51.6, 258.2) |
| Month 36 | 835 | 22.9 (21.4, 24.4) | 11 | 60.8 (23.7, 155.8) |
| Month 42 | 846 | 21.1 (19.8, 22.5) | 13 | 87.7 (36.9, 208.3) |
| HPV 52 | ||||
| Day 1 | 4455 | <3 (<3, <3) | 244 | 22.3 (20.3, 24.6) |
| Month 3 | 895 | 241.3 (229.7, 253.4) | 41 | 877.2 (543.0, 1417.0) |
| Month 7 | 4455 | 379.7 (371.6, 388.0) | 199 | 534.7 (447.2, 639.3) |
| Month 12 | 916 | 118.9 (113.0, 125.0) | 53 | 450.3 (320.3, 633.0) |
| Month 24 | 867 | 57.9 (54.7, 61.2) | 40 | 265.6 (175.1, 402.8) |
| Month 36 | 777 | 47.9 (45.0, 50.9) | 34 | 177.7 (120.2, 262.8) |
| Month 42 | 791 | 43.2 (40.6, 46.0) | 33 | 178.0 (120.8, 262.3) |
| HPV 58 | ||||
| Day 1 | 4486 | <4 (<4, <4) | 419 | 21.7 (19.9, 23.8) |
| Month 3 | 884 | 281.1 (265.3, 297.7) | 85 | 546.2 (436.4, 729.4) |
| Month 7 | 4486 | 482.5 (469.9, 495.3) | 342 | 606.2 (539.3, 681.5) |
| Month 12 | 905 | 153.3 (145.5, 161.6) | 108 | 273.4 (219.0, 341.2) |
| Month 24 | 852 | 80.3 (75.7, 85.3) | 84 | 147.4 (114.8, 189.3) |
| Month 36 | 765 | 55.0 (51.4, 58.8) | 79 | 101.3 (78.0, 131.6) |
| Month 42 | 784 | 52.0 (48.7, 55.6) | 76 | 95.1 (73.6, 122.9) |
n=number of subjects contributing to the analysis.
GMT, geometric mean titer (given in milli-Merck units per milliliter).
CI, confidence interval.