Table 2.
Positivity rates and GMTs of anti-HPV-16 and anti-HPV-18 type-specific IgG antibodies measured in cervicovaginal secretions by ELISA at Months 0, 7, 12, 18, 24, 36 and 48 (TVC, irrespective of serostatus and DNA status for the HPV type analyzed prior to vaccination)
| HPV-16/18 vaccine | HPV-6/11/16/18 vaccine | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Antigen | Month | N | n | % P [95% CI] | GMT* [95% CI] | N | n | % P [95% CI] | GMT* [95% CI] |
| HPV-16 | 0 | 57 | 2 | 3.5 [0.4, 12.1] | 15.6 [0.8, 321.3] | 64 | 0 | 0 [0.0,0.0] | – [–, –] |
| 7 | 65 | 62 | 95.4 [87.1, 99.0] | 200.4 [141.6, 283.6] | 82 | 74 | 90.2 [81.7, 95.7] | 92.9 [68.1, 126.5] | |
| 12 | 67 | 57 | 85.1 [74.3, 92.6] | 121.1 [88.6, 165.5] | 66 | 52 | 78.8 [67.0, 87.9] | 59.0 [43.5, 79.9] | |
| 18 | 51 | 42 | 82.4 [69.1, 91.6] | 102.1 [70.6, 147.8] | 65 | 41 | 63.1 [50.2, 74.7] | 68.8 [47.7, 99.1] | |
| 24 | 54 | 42 | 77.8 [64.4, 88.0] | 86.9 [60.7, 124.6] | 61 | 34 | 55.7 [42.4, 68.5] | 43.4 [27.8, 67.5] | |
| 36 | 60 | 43 | 71.7 [58.6, 82.5] | 57.7 [41.5, 80.4] | 62 | 42 | 67.7 [54.7, 79.1] | 51.5 [36.2, 73.2] | |
| 48 | 43 | 31 | 72.1 [56.3, 84.7] | 41.6 [29.3, 59.1] | 46 | 25 | 54.3 [39.0, 69.1] | 72.8 [38.5, 137.8] | |
| HPV-18 | 0 | 57 | 3 | 5.3 [1.1, 14.6] | 18.9 [8.8, 40.6] | 64 | 4 | 6.3 [1.7, 15.2] | 11.4 [1.4, 96.4] |
| 7 | 65 | 60 | 92.3 [83.0, 97.5] | 96.7 [73.1, 128.0] | 82 | 57 | 69.5 [58.4, 79.2] | 38.1 [28.0, 51.8] | |
| 12 | 67 | 54 | 80.6 [69.1, 89.2] | 57.6 [43.2, 76.7] | 67 | 35 | 52.2 [39.7, 64.6] | 36.4 [24.9, 53.1] | |
| 18 | 51 | 37 | 72.5 [58.3, 84.1] | 40.2 [25.7, 62.9] | 65 | 22 | 33.8 [22.6, 46.6] | 28.7 [16.5, 49.8] | |
| 24 | 54 | 38 | 70.4 [56.4, 82.0] | 49.0 [33.3, 72.0] | 61 | 22 | 36.1 [24.2, 49.4] | 20.8 [11.7, 36.8] | |
| 36 | 60 | 41 | 68.3 [55.0, 79.7] | 27.5 [20.3, 37.2] | 62 | 23 | 37.1 [25.2, 50.3] | 30.6 [17.8, 52.7] | |
| 48 | 43 | 24 | 55.8 [39.9, 70.9] | 24.1 [16.0, 36.2] | 46 | 18 | 39.1 [25.1, 54.6] | 26.1 [13.4, 50.9] | |
CI, confidence interval; GMT, geometric mean titer; N, number of subjects with available results; n, number of subjects with an antibody titer ≥ the limit of quantification; P, positivity (defined as antibody titer ≥0.58 ELISA units/mL for HPV-16 and ≥0.35 ELISA units/mL for HPV-18); TVC, total vaccinated cohort.
Month 7–Month 48 data are presented for the TVC corresponding to the time point under analysis.
*GMTs were calculated on positive subjects (n values) because data for all subjects in the subset did not follow a normal distribution. Dashes (–) indicate where there were insufficient values (i.e., n≤ 1) to calculate GMTs.