Clinical outcome
CIN
REGRESSION, CERVICAL INTRAEPITHELIAL NEOPLASIA, CIN
In per-protocol set analysis of 159 patients, histopathological regression to normal (complete response) occurred in 7 (17.1%) of 41 high-dose recipients and 4 (10.0%) of 40 placebo recipients at week 16 (rate difference = 7.1, 95% confidence interval [CI] = −9.4 to 23.9), while complete response occurred in 13 (31.7%) of 41 high-dose and 5 (12.5%) of 40 placebo recipients at week 24 (rate difference = 19.2, 95% CI = 0.5 to 37.8) (Rate of regression to normal (complete response). A forest plot analysis of differences in complete response rates between treatment and placebo for various subgroups is shown in Forest plots of differences in complete response rates for vaccine compared with placebo treatments in various subgroups. Rate differences and their 95% confidence intervals are shown in forest plots for complete response rate comparisons of various treatment vs placebo groups 24 weeks after the first vaccine dose. Patients with human papillomavirus (HPV)-16 and other HPV subtypes or cervical intraepithelial neoplasia 2 were small in number (approximately 10 patients), and complete response rates did not differ between treatment groups. CI = confidence interval; CIN = cervical intraepithelial neoplasia; FAS = full analysis set; HPV = human papillomavirus; PPS = per-protocol set; RD = rate difference. Bold means statistical difference.