Table 3.
Proportion of responders and geometric means for (a) HPV-16- and (b) HPV-18 type-specific CD4+ T-cell responses at Months 7, 12, 18, 24, 36 and 48 (ATP cohort for immunogenicity; seronegative, DNA-negative and HPV type-specific CD4+ T-cell negative prior to vaccination)
| Positivity rates | GM | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HPV-16/18 vaccine | HPV-6/11/16/18 vaccine | HPV-16/18 vaccine | HPV-6/11/16/18 vaccine | |||||||||||
| Antigen | Month | N | n | % P | N | n | % P | p-value* | N | GM (95% CI) | N | GM (95% CI) | GMR (95% CI) | p-value† |
| HPV-16 | 7 | 41 | 36 | 87.8 | 33 | 21 | 63.6 | 0.0245 | 41 | 1080 (853, 1369) | 33 | 665 (511, 865) | 1.63 (1.14, 2.32) | 0.0029 |
| 12 | 34 | 27 | 79.4 | 27 | 13 | 48.2 | 0.0151 | 34 | 794 (630, 1001) | 27 | 448 (345, 580) | 1.77 (1.25, 2.51) | 0.0008 | |
| 18 | 40 | 37 | 92.5 | 25 | 10 | 40.0 | < 0.0001 | 40 | 1149 (898, 1471) | 25 | 397 (291, 543) | 2.89 (1.94, 4.31) | < 0.0001 | |
| 24 | 33 | 30 | 90.9 | 20 | 12 | 60.0 | 0.0128 | 33 | 1070 (837, 1367) | 20 | 441 (322, 605) | 2.42 (1.63, 3.61) | < 0.0001 | |
| 36 | 20 | 16 | 80.0 | 15 | 6 | 40.0 | 0.0322 | 20 | 627 (292, 1346) | 15 | 285 (118, 688) | 2.20 (0.69, 7.07) | 0.0020 | |
| 48 | 13 | 12 | 92.3 | 14 | 5 | 35.7 | 0.0044 | 13 | 732 (314, 1707) | 14 | 498 (220, 1127) | 1.47 (0.45, 4.76) | 0.0057 | |
| HPV-18 | 7 | 43 | 34 | 79.1 | 40 | 23 | 57.5 | 0.0571 | 43 | 907 (668, 1232) | 40 | 507 (370, 697) | 1.79 (1.15, 2.78) | 0.0102 |
| 12 | 38 | 26 | 68.4 | 32 | 11 | 34.4 | 0.0078 | 38 | 461 (285, 747) | 32 | 315 (186, 533) | 1.46 (0.72, 2.99) | 0.0131 | |
| 18 | 42 | 33 | 78.6 | 33 | 14 | 42.4 | 0.0018 | 42 | 842 (572, 1240) | 33 | 314 (203, 486) | 2.68 (1.50, 4.81) | 0.0006 | |
| 24 | 35 | 26 | 74.3 | 25 | 10 | 40.0 | 0.0152 | 35 | 694 (488, 987) | 25 | 294 (194, 446) | 2.36 (1.37, 4.08) | 0.0003 | |
| 36 | 22 | 12 | 54.6 | 17 | 5 | 29.4 | 0.1930 | 22 | 352 (189, 653) | 17 | 243 (120, 492) | 1.45 (0.57, 3.70) | 0.0210 | |
| 48 | 14 | 11 | 78.6 | 15 | 5 | 33.3 | 0.0253 | 14 | 740 (415, 1319) | 15 | 257 (147, 449) | 2.88 (1.29, 6.44) | 0.0088 | |
ATP, according-to-protocol; CI, confidence interval; GM, geometric mean (calculated from responder [defined as subjects with detectable HPV type-specific memory CD4+ T-cells, i.e., > 500 HPV-specific CD4+ T-cells/million CD4+ T-cells] and non-responder data); GMR, geometric mean ratio; N, number of subjects with available results; n, number of positive subjects; P, positivity (defined as > 500 HPV-specific CD4+ T-cells/million CD4+ T-cells).
Month 7–Month 48 data are presented for the ATP cohort for immunogenicity corresponding to the time point under analysis.
*For the comparison of proportions of responders, p-values were calculated using Fisher's exact test. †For statistical assessment of CD4+ T-cell GM ratios, p-values were computed using a Kruskal-Wallis model.