Table 4.
Summary of Anti-HPV cLIA GMTs and Seropositivity at Month 7 in Asian Participants (Young Women Aged 16–26 Years) in the PPI Population in Study 001 by Vaccination Group and Country
| Assay (cLIA) | 9vHPV Vaccine | qHPV Vaccine | 9vHPV Vaccine | qHPV Vaccine | ||||
|---|---|---|---|---|---|---|---|---|
| n | GMT (95% CI), mMU/mL | n | GMT (95% CI), mMU/mL | m | Seropositive (95% CI), % | m | Seropositive (95% CI), % | |
| Hong Kong and Taiwan | N = 313 | N = 312 | N = 313 | N = 312 | ||||
| Anti–HPV-6 | 229 | 734.6 (660.0–817.7) | 237 | 718.0 (646.2–797.7) | 227 | 99.1 (96.9–99.9) | 235 | 99.2 (97.0–99.9) |
| Anti–HPV-11 | 230 | 496.5 (443.1–556.2) | 237 | 616.5 (551.2–689.5) | 229 | 99.6 (97.6–100) | 236 | 99.6 (97.7–100) |
| Anti–HPV-16 | 237 | 2654.6 (2394.3–2943.1) | 245 | 2579.9 (2330.9–2855.5) | 237 | 100 (98.5–100) | 244 | 99.6 (97.7–100) |
| Anti–HPV-18 | 245 | 790.6 (698.5–894.7) | 259 | 669.4 (593.4–755.0) | 244 | 99.6 (97.7–100) | 258 | 99.6 (97.9–100) |
| Anti–HPV-31 | 247 | 607.4 (524.1–703.9) | 260 | 8.5 (7.3–9.8) | 245 | 99.2 (97.1–99.9) | 126 | 48.5 (42.2–54.7) |
| Anti–HPV-33 | 245 | 383.5 (339.2–433.6) | 260 | <4 (<4 to <4) | 242 | 98.8 (96.5–99.7) | 29 | 11.2 (7.6–15.6) |
| Anti–HPV-45 | 250 | 234.6 (206.7–266.2) | 264 | <3 (<3 to <3) | 246 | 98.4 (96.0–99.6) | 24 | 9.1 (5.9–13.2) |
| Anti–HPV-52 | 231 | 313.4 (279.0–352.1) | 238 | <3 (<3 to <3) | 229 | 99.1 (96.9–99.9) | 10 | 4.2 (2.0–7.6) |
| Anti–HPV-58 | 236 | 487.2 (429.4–552.8) | 257 | <4 (<4 to <4) | 234 | 99.2 (97.0, 99.9) | 39 | 15.2 (11.0–20.2) |
| Japan | N = 127 | N = 127 | N = 127 | N = 127 | ||||
| Anti–HPV-6 | 93 | 839.7 (696.3–1012.7) | 100 | 621.2 (518.5–744.1) | 93 | 100 (96.1–100) | 98 | 98.0 (93.0–99.8) |
| Anti–HPV-11 | 93 | 611.1 (516.4–723.3) | 100 | 607.3 (516.2–714.5) | 93 | 100 (96.1–100) | 100 | 100 (96.4–100) |
| Anti–HPV-16 | 96 | 2672.7 (2269.6–3147.3) | 103 | 2223.4 (1898.7–2603.5) | 96 | 100 (96.2–100) | 103 | 100 (96.5–100) |
| Anti–HPV-18 | 99 | 688.7 (563.3–842.0) | 109 | 471.9 (389.6–571.5) | 99 | 100 (96.3–100) | 106 | 97.2 (92.2–99.4) |
| Anti–HPV-31 | 104 | 672.3 (552.4–818.2) | 109 | 5.9 (4.9–7.2) | 104 | 100 (96.5–100) | 37 | 33.9 (25.1–43.6) |
| Anti–HPV-33 | 109 | 398.3 (344.8–460.2) | 111 | <4 (<4 to <4) | 109 | 100 (96.7–100) | 11 | 9.9 (5.1–17.0) |
| Anti–HPV-45 | 111 | 258.5 (224.8–297.3) | 111 | <3 (<3 to <3) | 111 | 100 (96.7–100) | 6 | 5.4 (2.0–11.4) |
| Anti–HPV-52 | 98 | 306.3 (267.5–350.7) | 96 | <3 (<3 to <3) | 98 | 100 (96.3–100) | 4 | 4.2 (1.1–10.3) |
| Anti–HPV-58 | 95 | 459.6 (399.9–528.3) | 99 | <4 (<4 to <4) | 95 | 100 (96.2–100) | 12 | 12.1 (6.4–20.2) |
| South Korea | N = 152 | N = 151 | N = 152 | N = 151 | ||||
| Anti–HPV-6 | 94 | 820.1 (684.3–982.8) | 88 | 801.9 (665.1–966.9) | 92 | 97.9 (92.5–99.7) | 88 | 100 (95.9–100) |
| Anti–HPV-11 | 94 | 613.0 (518.3–724.9) | 88 | 658.2 (553.5–782.8) | 94 | 100 (96.2–100) | 88 | 100 (95.9–100) |
| Anti–HPV-16 | 103 | 2641.6 (2323.2–3003.7) | 99 | 2691.6 (2361.0–3068.3) | 103 | 100 (96.5–100) | 99 | 100 (96.3–100) |
| Anti–HPV-18 | 109 | 634.9 (531.0–759.1) | 104 | 627.0 (522.2–752.8) | 108 | 99.1 (95.0–100) | 104 | 100 (96.5–100) |
| Anti–HPV-31 | 113 | 553.9 (455.4–673.8) | 99 | 7.6 (6.2–9.4) | 112 | 99.1 (95.2–100) | 45 | 45.5 (35.4–55.8) |
| Anti–HPV-33 | 112 | 337.2 (297.1–382.6) | 102 | <4 (<4 to <4) | 112 | 100 (96.8–100) | 5 | 4.9 (1.6–11.1) |
| Anti–HPV-45 | 114 | 213.8 (183.0–249.6) | 102 | <3 (<3 to <3) | 113 | 99.1 (95.2–100) | 5 | 4.9 (1.6–11.1) |
| Anti–HPV-52 | 100 | 310.5 (262.0–368.0) | 93 | <3 (<3 to <3) | 100 | 100 (96.4–100) | 3 | 3.2 (0.7–9.1) |
| Anti–HPV-58 | 104 | 420.1 (361.3–488.5) | 99 | <4 (<4 to <4) | 104 | 100 (96.5–100) | 15 | 15.2 (8.7–23.8) |
| Thailand | N = 232 | N = 233 | N = 232 | N = 233 | ||||
| Anti–HPV-6 | 158 | 910.5 (806.4–1028.0) | 168 | 832.5 (740.0–936.5) | 158 | 100 (97.7–100) | 168 | 100 (97.8–100) |
| Anti–HPV-11 | 158 | 668.1 (586.2–761.4) | 168 | 736.7 (649.0–836.3) | 158 | 100 (97.7–100) | 168 | 100 (97.8–100) |
| Anti–HPV-16 | 172 | 3479.4 (3125.1–3873.9) | 182 | 3371.3 (3037.1–3742.3) | 172 | 100 (97.9–100) | 182 | 100 (98.0–100) |
| Anti–HPV-18 | 181 | 1095.5 (960.7–1249.2) | 183 | 890.7 (781.7–1014.9) | 181 | 100 (98.0–100) | 183 | 100 (98.0–100) |
| Anti–HPV-31 | 195 | 809.1 (687.0–952.9) | 189 | 14.2 (12.0–16.8) | 194 | 99.5 (97.2–100) | 117 | 61.9 (54.6–68.9) |
| Anti–HPV-33 | 189 | 473.3 (415.1–539.7) | 196 | <4 (<4 to <4) | 188 | 99.5 (97.1–100) | 28 | 14.3 (9.7–20.0) |
| Anti–HPV-45 | 200 | 357.8 (313.7–408.0) | 201 | <3 (<3 to <3) | 199 | 99.5 (97.2–100) | 24 | 11.9 (7.8–17.2) |
| Anti–HPV-52 | 172 | 387.7 (343.1–438.2) | 174 | <3 (<3 to <3) | 171 | 99.4 (96.8–100) | 8 | 4.6 (2.0–8.9) |
| Anti–HPV-58 | 177 | 545.0 (481.8–616.4) | 184 | <4 (<4 to 4.2) | 177 | 100 (97.9–100) | 39 | 21.2 (15.5–27.8) |
| Total | N = 824 | N = 823 | N = 824 | N = 823 | ||||
| Anti–HPV-6 | 574 | 810.9 (756.9–868.7) | 593 | 742.7 (694.1–794.8) | 570 | 99.3 (98.2–99.8) | 589 | 99.3 (98.3–99.8) |
| Anti–HPV-11 | 575 | 576.6 (537.7–618.3) | 593 | 653.1 (609.7–699.6) | 574 | 99.8 (99.0–100) | 592 | 99.8 (99.1–100) |
| Anti–HPV-16 | 608 | 2866.4 (2695.9–3047.8) | 629 | 2738.7 (2578.4–2908.9) | 608 | 100 (99.4–100) | 628 | 99.8 (99.1–100) |
| Anti–HPV-18 | 634 | 817.8 (757.7–882.7) | 655 | 676.9 (628.0–729.7) | 632 | 99.7 (98.9–100) | 651 | 99.4 (98.4–99.8) |
| Anti–HPV-31 | 659 | 661.3 (605.5–722.2) | 657 | 9.1 (8.3–10.0) | 655 | 99.4 (98.5–99.8) | 325 | 49.5 (45.6–53.4) |
| Anti–HPV-33 | 655 | 401.2 (374.8–429.5) | 669 | < 4 (<4 to <4) | 651 | 99.4 (98.4–99.8) | 73 | 10.9 (8.7–13.5) |
| Anti–HPV-45 | 675 | 265.9 (247.7–285.5) | 678 | < 3 (<3 to <3) | 669 | 99.1 (98.1–99.7) | 59 | 8.7 (6.7–11.1) |
| Anti–HPV-52 | 601 | 331.3 (309.8–354.3) | 601 | < 3 (<3 to <3) | 598 | 99.5 (98.5–99.9) | 25 | 4.2 (2.7–6.1) |
| Anti–HPV-58 | 612 | 486.3 (453.8–521.1) | 639 | < 4 (<4 to <4) | 610 | 99.7 (98.8–100) | 105 | 16.4 (13.6–19.5) |
The PPI population included all participants who had no protocol violation that could interfere with the evaluation of the immune response to vaccine as judged by the study director, received all 3 vaccinations within acceptable day ranges, were seronegative at day 1 and PCR negative day 1 through month 7 for the relevant HPV type(s), and had a month 7 serum sample collected within an acceptable day range.
Seropositive percent represents proportion of participants with anti-HPV serum levels ≥30, 16, 20, 24, 10, 8, 8, 8, and 8 mMU/mL for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, respectively.
Abbreviations: 9vHPV, 9-valent human papillomavirus; CI, confidence interval; cLIA, competitive Luminex immunoassay; GMT, geometric mean titer; mMU, milli-Merck units; PPI, per-protocol immunogenicity; qHPV, quadrivalent human papillomavirus.
N = number of participants randomized to the respective vaccination group who received at least 1 injection. n = number of participants contributing to the analysis. m = number of participants who had seroconversion.