Table 5.
Summary of Anti-HPV cLIA GMTs and Seropositivity at Month 7 in the PPI Population of Asian Girls and Boys (Aged 9–15 Years) in Study 002, by Country, and the Overall Population of Young Women (Aged 16–26 Years) From Study 001
| Assay (cLIA) | Study 002 | Study 001a | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9vHPV Vaccine (Girls and Boys Aged 9–15 y) | 9vHPV Vaccine (Women Aged 16–26 y) | |||||||||||
| India (N = 200) | South Korea (N = 129) | Taiwan (N = 139) | Thailand (N = 140) | Total (N = 608) | Overall Study Population (N = 6792) | |||||||
| n | GMT (95% CI), mMU/mL | n | GMT (95% CI), mMU/mL | n | GMT (95% CI), mMU/mL | n | GMT (95% CI), mMU/mL | n | GMT (95% CI), mMU/mL | n | GMT (95% CI), mMU/mL | |
| Anti–HPV-6 | 170 | 1641.2 (1428.0–1886.2) | 120 | 2226.3 (1931.8–2565.6) | 134 | 1308.8 (1129.9–1516.0) | 131 | 1464.8 (1277.5–1679.6) | 555 | 1615.9 (1503.3–1736.8) | 3993 | 893.1 (871.7–915.1) |
| Anti–HPV-11 | 170 | 1180.0 (1024.2–1359.5) | 120 | 1524.0 (1318.2–1761.9) | 134 | 956.6 (836.9–1093.5) | 131 | 1024.5 (888.4–1181.5) | 555 | 1146.6 (1067.2–1231.9) | 3995 | 666.3 (649.6–683.4) |
| Anti–HPV-16 | 175 | 7061.4 (6125.2–8140.8) | 121 | 8265.5 (7182.8–9511.5) | 135 | 5804.4 (5142.0–6552.1) | 135 | 6598.6 (5742.3–7582.6) | 566 | 6857.8 (6399.4–7349.0) | 4032 | 3131.1 (3057.1–3206.9) |
| Anti–HPV-18 | 178 | 2118.5 (1798.9–2494.9) | 120 | 2530.4 (2147.5–2981.7) | 137 | 1688.0 (1469.3–1939.3) | 132 | 2433.7 (2081.7–2845.1) | 567 | 2150.5 (1986.0–2328.8) | 4539 | 804.6 (782.7–827.1) |
| Anti–HPV-31 | 171 | 1666.0 (1453.4–1909.7) | 119 | 2177.4 (1864.5–2542.9) | 136 | 1636.2 (1424.7–1879.1) | 133 | 1748.3 (1518.0–2013.7) | 559 | 1776.3 (1654.0–1907.6) | 4466 | 658.4 (636.7–680.9) |
| Anti–HPV-33 | 175 | 855.0 (736.9–992.0) | 121 | 1053.1 (907.2–1222.4) | 137 | 796.4 (696.6–910.5) | 134 | 891.4 (777.0–1022.6) | 567 | 887.4 (825.7–953.7) | 4702 | 415.9 (405.6–426.4) |
| Anti–HPV-45 | 179 | 742.0 (627.4–877.5) | 121 | 900.1 (746.6–1085.2) | 137 | 715.2 (602.4–849.0) | 134 | 787.2 (675.7–917.1) | 571 | 776.9 (713.6–845.9) | 4792 | 252.8 (246.2–259.6) |
| Anti–HPV-52 | 176 | 827.0 (708.2–965.8) | 121 | 1005.9 (866.0–1168.5) | 136 | 779.0 (668.6–907.7) | 134 | 753.8 (657.1–864.8) | 567 | 831.6 (771.1–896.9) | 4455 | 379.7 (371.6–388.0) |
| Anti–HPV-58 | 173 | 1198.1 (1030.5–1393.0) | 121 | 1572.7 (1362.8–1814.9) | 136 | 1152.8 (1006.3–1320.7) | 133 | 1209.3 (1045.5–1398.9) | 563 | 1261.2 (1172.3–1357.0) | 4486 | 482.5 (469.9–495.3) |
| Assay (cLIA) | m | Seropositive (95% CI), % | m | Seropositive (95% CI), % | m | Seropositive (95% CI), % | m | Seropositive (95% CI), % | m | Seropositive (95% CI), % | m | Seropositive (95% CI), % |
| Anti–HPV-6 | 168 | 98.8 (95.8–99.9) | 120 | 100 (97.0–100) | 133 | 99.3 (95.9–100) | 131 | 100 (97.2–100) | 552 | 99.5 (98.4–99.9) | 3985 | 99.8 (99.6–99.9) |
| Anti–HPV-11 | 169 | 99.4 (96.8–100) | 120 | 100 (97.0–100) | 134 | 100 (97.3–100) | 131 | 100 (97.2–100) | 554 | 99.8 (99.0–100) | 3994 | 100 (99.9–100) |
| Anti–HPV-16 | 174 | 99.4 (96.9–100) | 121 | 100 (97.0–100) | 135 | 100 (97.3–100) | 135 | 100 (97.3–100) | 565 | 99.8 (99.0–100) | 4031 | 100 (99.9–100) |
| Anti–HPV-18 | 177 | 99.4 (96.9–100) | 120 | 100 (97.0–100) | 137 | 100 (97.3–100) | 132 | 100 (97.2–100) | 566 | 99.8 (99.0–100) | 4532 | 99.8 (99.7–99.9) |
| Anti–HPV-31 | 171 | 100 (97.9–100) | 119 | 100 (96.9–100) | 136 | 100 (97.3–100) | 133 | 100 (97.3–100) | 559 | 100 (99.3–100) | 4457 | 99.8 (99.6–99.9) |
| Anti–HPV-33 | 174 | 99.4 (96.9–100) | 121 | 100 (97.0–100) | 137 | 100 (97.3–100) | 134 | 100 (97.3–100) | 566 | 99.8 (99.0–100) | 4689 | 99.7 (99.5–99.9) |
| Anti–HPV-45 | 178 | 99.4 (96.9–100) | 121 | 100 (97.0–100) | 137 | 100 (97.3–100) | 134 | 100 (97.3–100) | 570 | 99.8 (99.0–100) | 4773 | 99.6 (99.4–99.8) |
| Anti–HPV-52 | 175 | 99.4 (96.9–100) | 121 | 100 (97.0–100) | 136 | 100 (97.3–100) | 134 | 100 (97.3–100) | 566 | 99.8 (99.0–100) | 4446 | 99.8 (99.6–99.9) |
| Anti–HPV-58 | 172 | 99.4 (96.8–100) | 121 | 100 (97.0–100) | 136 | 100 (97.3–100) | 133 | 100 (97.3–100) | 562 | 99.8 (99.0–100) | 4476 | 99.8 (99.6–99.9) |
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 (16 to 26-year-old women only) 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 the 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.
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.
aBased on [19].