Table 1.
HPV16/18 Vaccine efficacy against prevalent cervical, anal, and oral HPV16/18 DNA four years after vaccination in the full cohort
| Anatomic site | Arm | Women or sites | Events | HPV16/18 prevalence, % | Efficacy (95% CI), % |
|---|---|---|---|---|---|
| Cervical, anal, or oral HPV16/18 multisite woman-level* |
HPV vaccine | 2094 | 81 | 3.9 | 64.8 (54.8 to 72.8) |
| Control | 2092 | 230 | 11.0 | ||
| Cervical HPV16/18 | HPV vaccine | 2094 | 40 | 1.9 | 76.4 (66.9 to 83.4) |
| Control | 2092 | 169 | 8.1 | ||
| Anal HPV16/18 | HPV vaccine | 2094 | 47 | 2.2 | 62.1 (47.3 to 73.1) |
| Control | 2092 | 124 | 5.9 | ||
| Oral HPV16/18 | HPV vaccine | 2094 | 0 | 0.0 | 100.0 (60.5 to 100.0) |
| Control | 2092 | 9 | 0.4 | ||
| Cervical, anal, oral HPV16/18 multisite infection level† |
HPV vaccine | 6282 | 87 | 1.4 | 71.2 (62.8 to 77.7) |
| Control | 6276 | 302 | 4.8 | ||
| HPV16/18 at two or three sites | HPV vaccine | 2094 | 6 | 0.3 | 91.4 (81.4 to 96.6) |
| Control | 2092 | 70 | 3.3 |
* A woman-level event is defined as a woman who is positive for cervical, anal, and/or oral human papillomavirus DNA at the four-year visit. CI = confidence interval; HPV = human papillomavirus; VE = vaccine efficacy. † An infection-level event is defined as a woman’s anatomical site having HPV16/18 DNA (women contribute three times for each anatomic site); the VEs for this analysis utilized generalized estimating equations to adjust for the correlation within an individual.