Table 1.
Seropositivity rates, GMTs and GMT ratios for serum anti-HPV-16 and anti-HPV-18 type-specific neutralizing antibodies measured by PBNA at Months 7, 12, 18, 24, 36 and 48 (ATP cohort for immunogenicity, seronegative and DNA-negative for the HPV type analyzed prior to vaccination)
| HPV-16/18 vaccine | HPV-6/11/16/18 vaccine | |||||||
|---|---|---|---|---|---|---|---|---|
| Antigen | Month | N | % SP [95% CI] | GMT [95% CI] | N | % SP [95% CI] | GMT [95% CI] | GMT Ratio* |
| A | 18–26 years | |||||||
| HPV-16 | 7 | 104 | 100 [96.5, 100] | 36792 [29266, 46254] | 103 | 100 [96.5, 100] | 10053 [8136, 12422] | 3.7 [2.6, 5.2] |
| 12 | 101 | 100 [96.4, 100] | 14525 [11070, 19058] | 99 | 100 [96.3, 100] | 3265 [2545, 4190] | 4.5 [3.1, 6.4] | |
| 18 | 100 | 100 [96.4, 100] | 6000 [4681, 7691] | 91 | 100 [96.0, 100] | 1183 [883, 1585] | 5.1 [3.5, 7.4] | |
| 24 | 97 | 100 [96.3, 100] | 5184 [4015, 6694] | 89 | 97.8 [92.1, 99.7] | 894 [672, 1188] | 5.8 [4.0, 8.5] | |
| 36 | 60 | 100 [94.0, 100] | 3845 [2804, 5272] | 62 | 98.4 [91.3, 100] | 653 [460, 927] | 5.9 [3.7, 9.4] | |
| 48 | 54 | 100 [93.4, 100] | 3901 [2745, 5543] | 57 | 98.2 [90.6, 100] | 750 [505, 1115] | 5.2 [3.1, 8.8] | |
| HPV-18 | 7 | 118 | 100 [96.9, 100] | 16487 [13383, 20310] | 131 | 100 [97.2, 100] | 2258 [1809, 2818] | 7.3 [5.1, 10.4] |
| 12 | 112 | 100 [96.8, 100] | 4472 [3528, 5669] | 127 | 96.1 [91.1, 98.7] | 596 [469, 757] | 7.5 [5.4, 10.5] | |
| 18 | 109 | 100 [96.7, 100] | 2256 [1762, 2890] | 114 | 93.0 [86.6, 96.9] | 249 [195, 318] | 9.1 [6.4, 12.8] | |
| 24 | 106 | 100 [96.6, 100] | 1652 [1296, 2105] | 109 | 84.4 [76.2, 90.6] | 175 [133, 231] | 9.4 [6.5, 13.6] | |
| 36 | 64 | 100 [94.4, 100] | 1594 [1177, 2158] | 76 | 78.9 [68.1, 87.5] | 128 [92.6, 177] | 12.5 [8.0, 19.5] | |
| 48 | 59 | 100 [93.9, 100] | 1711 [1180, 2482] | 70 | 81.4 [70.3, 89.7] | 139 [98.7, 196] | 12.3 [7.5, 20.3] | |
| B | 27–35 years | |||||||
| HPV-16 | 7 | 90 | 100 [96.0, 100] | 23908 [18913, 30222] | 85 | 100 [95.8, 100] | 4958 [3896, 6311] | 4.8 [3.3, 7.1] |
| 12 | 91 | 100 [96.0, 100] | 7419 [5592, 9843] | 85 | 98.8 [93.6, 100] | 1756 [1290, 2390] | 4.2 [2.8, 6.4] | |
| 18 | 87 | 100 [95.8, 100] | 2908 [2229, 3793] | 83 | 98.8 [93.5, 100] | 690 [506, 941] | 4.2 [2.8, 6.3] | |
| 24 | 84 | 100 [95.7, 100] | 2269 [1766, 2916] | 79 | 97.5 [91.2, 99.7] | 619 [447, 856] | 3.7 [2.5, 5.5] | |
| 36 | 63 | 100 [94.3, 100] | 1898 [1419, 2538] | 49 | 100 [92.7, 100] | 502 [347, 726] | 3.8 [2.4, 6.0] | |
| 48 | 54 | 100 [93.4, 100] | 2046 [1469, 2850] | 51 | 96.1 [86.5, 99.5] | 678 [433, 1060] | 3.0 [1.8, 5.2] | |
| HPV-18 | 7 | 102 | 100 [96.4, 100] | 9502 [7519, 12008] | 101 | 98.0 [93.0, 99.8] | 1043 [790, 1378] | 9.1 [6.0, 13.8] |
| 12 | 105 | 99.0 [94.8, 100] | 2266 [1765, 2910] | 102 | 90.2 [82.7, 95.2] | 280 [209, 376] | 8.1 [5.5, 11.8] | |
| 18 | 101 | 100 [96.4, 100] | 1302 [1011, 1677] | 99 | 74.7 [65.0, 82.9] | 133 [101, 176] | 9.8 [6.7, 14.2] | |
| 24 | 98 | 100 [96.3, 100] | 1028 [801, 1320] | 94 | 72.3 [62.2, 81.1] | 116 [87.4, 155] | 8.9 [6.1, 12.9] | |
| 36 | 75 | 100 [95.2, 100] | 943 [713, 1247] | 61 | 70.5 [57.4, 81.5] | 102 [69.6, 149] | 9.3 [5.9, 14.6] | |
| 48 | 66 | 100 [94.6, 100] | 982 [741, 1302] | 59 | 57.6 [44.1, 70.4] | 76.9 [52.7, 112] | 12.8 [8.1, 20.2] | |
| C | 36–45 years | |||||||
| HPV-16 | 7 | 96 | 100 [96.2, 100] | 17302 [13605, 22002] | 83 | 100 [95.7, 100] | 7634 [5916, 9853] | 2.3 [1.5, 3.4] |
| 12 | 89 | 100 [95.9, 100] | 7110 [5386, 9386] | 83 | 100 [95.7, 100] | 2678 [1987, 3610] | 2.7 [1.8, 4.0] | |
| 18 | 90 | 100 [96.0, 100] | 2344 [1808, 3039] | 82 | 100 [95.6, 100] | 995 [733, 1350] | 2.4 [1.6, 3.5] | |
| 24 | 87 | 100 [95.8, 100] | 2059 [1592, 2661] | 80 | 100 [95.5, 100] | 875 [637, 1201] | 2.4 [1.6, 3.5] | |
| 36 | 61 | 100 [94.1, 100] | 1794 [1278, 2519] | 57 | 100 [93.7, 100] | 824 [567, 1196] | 2.2 [1.3, 3.6] | |
| 48 | 51 | 98.0 [89.6, 100] | 2081 [1378, 3144] | 54 | 98.1 [90.1, 100] | 1019 [645, 1608] | 2.0 [1.1, 3.8] | |
| HPV-18 | 7 | 110 | 100 [96.7, 100] | 9846 [7835, 12372] | 91 | 100 [96.0, 100] | 1439 [1105, 1873] | 6.8 [4.6, 10.2] |
| 12 | 104 | 100 [96.5, 100] | 3032 [2321, 3962] | 91 | 98.9 [94.0, 100] | 434 [325, 579] | 7.0 [4.7, 10.3] | |
| 18 | 103 | 99.0 [94.7, 100] | 1427 [1084, 1878] | 91 | 86.8 [78.1, 93.0] | 182 [137, 241] | 7.9 [5.3, 11.6] | |
| 24 | 100 | 99.0 [94.6, 100] | 1040 [786, 1377] | 88 | 77.3 [67.1, 85.5] | 136 [99.0, 186] | 7.7 [5.0, 11.6] | |
| 36 | 71 | 97.2 [90.2, 99.7] | 904 [625, 1306] | 61 | 73.8 [60.9, 84.2] | 103 [74.6, 143] | 8.8 [5.3, 14.4] | |
| 48 | 61 | 96.7 [88.7, 99.6] | 785 [529, 1164] | 61 | 72.1 [59.2, 82.9] | 91.5 [67.0, 125] | 8.6 [5.2, 14.1] | |
CI, confidence interval; GMT, geometric mean titer; N, number of subjects with available results; PBNA, pseudovirion-based neutralization assay; SP, seropositivity (defined as neutralizing antibody titer ≥40 ED50 [effective dose producing 50% response]).
Month 7–Month 48 data are presented for the ATP cohort for immunogenicity corresponding to the time point under analysis.
*GMT ratio, GMT in the HPV-16/18 group divided by GMT in the HPV-6/11/16/18 group; Month 7 GMT ratios are provided with 97.6% CI while Month 12–Month 48 GMT ratios are provided with 95% CI.
The ATP cohort for immunogenicity included all evaluable subjects who received 3 vaccine doses (i.e., those meeting all eligibility criteria and complying with the procedures defined in the protocol) for whom data concerning immunogenicity endpoint measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen (HPV-16 or HPV-18) at the time point under analysis.