Table 5.
HPV16/18 vaccine efficacy among individuals with cervical HPV16 or HPV18 DNA detected at enrollment
Study population | Arm | Women or sites | No. events | HPV prevalence, % | Efficacy (95% CI), % |
---|---|---|---|---|---|
Anal or oral HPV16/18 at the four-year visit | HPV vaccine | 192 | 16 | 8.3 | 25.3 (-40.4 to 61.1) |
Control | 215 | 24* | 11.2 | ||
Redetection of cervical HPV16/18 (among women with HPV16/18 at enrollment who subsequently cleared their infection)† | HPV vaccine | 180 | 10 | 5.6 | 38.9 (-31.7 to 72.9) |
Control | 198 | 18 | 9.1 | ||
HPV16/18 at two or three sites at the four-year visit | HPV vaccine | 192 | 3 | 1.6 | 44.0 (-124.9 to 88.6) |
Control | 215 | 6 | 2.8 |
* Only two of the 40 total anal/oral events were oral HPV16/18 infections. These two oral HPV16/18 infections were both detected in the control arm, but oral HPV16/18-specific vaccine efficacy did not approach statistical significance given its small sample size. CI = confidence interval; HPV = human papillomavirus. † Clearance defined as one negative cervical HPV16/18 DNA test after the positive cervical HPV16/18 DNA test.