Table 3.
VE against incident and persistent infection, cytological abnormalities and CIN associated with HPV-16 and/or HPV-18 in women who were HPV DNA negative and seronegative at baseline for the corresponding HPV type (TVC for efficacy)
| Vaccine |
Control |
||||||
|---|---|---|---|---|---|---|---|
| Endpoint | N | n | Event rate (95% CI)1 | N | n | Event rate (95% CI)1 | VE (95% CI) |
| 6-Month PI and/or CIN1+ (primary endpoint) | |||||||
| HPV-16/182 | 2,543 | 4 | 0.09 (0.02, 0.23) | 2,554 | 36 | 0.83 (0.58, 1.15) | 88.9% (69.1, 97.1) |
| HPV-16 | 1,975 | 3 | 0.09 (0.02, 0.26) | 1,930 | 24 | 0.74 (0.47, 1.10) | 87.8% (60.0, 97.7) |
| HPV-18 | 2,362 | 1 | 0.02 (0.00, 0.14) | 2,366 | 13 | 0.32 (0.17, 0.55) | 92.3% (48.9, 99.8) |
| Incident infection | |||||||
| HPV-16/182 | 2,609 | 30 | 0.69 (0.46, 0.98) | 2,637 | 78 | 1.79 (1.41, 2.23) | 61.6% (40.9, 75.7) |
| HPV-16 | 2,021 | 19 | 0.57 (0.34, 0.88) | 1,995 | 48 | 1.47 (1.08, 1.94) | 61.4% (33.1, 78.6) |
| HPV-18 | 2,423 | 13 | 0.32 (0.17, 0.55) | 2,441 | 35 | 0.86 (0.60, 1.20) | 62.9% (28.2, 82.0) |
| 6-Month PI | |||||||
| HPV-16/182 | 2,517 | 3 | 0.07 (0.01, 0.20) | 2,531 | 33 | 0.76 (0.53, 1.07) | 91.0% (71.2, 98.2) |
| HPV-16 | 1,959 | 2 | 0.06 (0.01, 0.22) | 1,915 | 21 | 0.65 (0.40, 0.99) | 90.7% (62.1, 99.0) |
| HPV-18 | 2,340 | 1 | 0.02 (0.00, 0.14) | 2,346 | 13 | 0.32 (0.17, 0.55) | 92.3% (49.0, 99.8) |
| 12-month PI | |||||||
| HPV-16/182 | 2,411 | 2 | 0.05 (0.01, 0.17) | 2,434 | 12 | 0.28 (0.15, 0.49) | 83.3% (24.9, 98.2) |
| HPV-16 | 1,877 | 1 | 0.03 (0.00, 0.17) | 1,839 | 7 | 0.22 (0.09, 0.45) | 86.0% (−8.7, 99.7) |
| HPV-18 | 2,242 | 1 | 0.03 (0.00, 0.14) | 2,260 | 5 | 0.13 (0.04, 0.30) | 80.0% (−79.2, 99.6) |
| Any cytological abnormality (ASC-US+) | |||||||
| HPV-16/182 | 2,539 | 3 | 0.08 (0.02, 0.23) | 2,552 | 26 | 0.69 (0.45, 1.01) | 88.5% (62.5, 97.8) |
| HPV-16 | 1,972 | 2 | 0.07 (0.01, 0.25) | 1,929 | 19 | 0.68 (0.41, 1.06) | 89.7% (57.5, 98.8) |
| HPV-18 | 2,358 | 1 | 0.03 (0.00, 0.16) | 2,365 | 9 | 0.26 (0.12, 0.49) | 88.9% (20.1, 99.8) |
| CIN1+ | |||||||
| HPV-16/182 | 2,543 | 1 | 0.03 (0.00, 0.15) | 2,554 | 6 | 0.16 (0.06, 0.34) | 83.3% (−37.3, 99.6) |
| HPV-16 | 1,975 | 1 | 0.03 (0.00, 0.19) | 1,930 | 6 | 0.21 (0.08, 0.46) | 83.7% (−34.3, 99.7) |
| HPV-18 | 2,362 | 0 | 0.00 (0.00, 0.10) | 2,366 | 0 | 0.00 (0.00, 0.10) | – |
| CIN2+ | |||||||
| HPV-16/182 | 2,543 | 0 | 0.00 (0.00, 0.10) | 2,554 | 4 | 0.11 (0.03, 0.27) | 100% (−51.4, 100) |
| HPV-16 | 1,975 | 0 | 0.00 (0.00, 0.13) | 1,930 | 4 | 0.14 (0.04, 0.36) | 100% (−48.0, 100) |
| HPV-18 | 2,362 | 0 | 0.00 (0.00, 0.10) | 2,366 | 0 | 0.00 (0.00, 0.10) | – |
ASC-US+: atypical squamous cells of undetermined significance or higher; CIN1+: cervical intraepithelial neoplasia grade 1 or higher; CIN2+: cervical intraepithelial neoplasia grade 2 or higher; N: number of evaluable women in each group (for single HPV type women had to be DNA negative and seronegative for the corresponding HPV type at month 0; for combined HPV types women had to be DNA negative and seronegative for at least one HPV type at month 0); n: number of evaluable women reporting at least one event in each group; CI: confidence interval; PI: persistent infection.
Number of cases divided by sum of follow-up period (per 100 woman years); follow-up period started on day after first vaccine dose.
Women could be infected with one or both HPV types (thus, number of women with a HPV-16-associated lesion and number with a HPV-18-associated lesion might not equal number of women with a HPV-16/18-associated lesion).