Table 1.
Primary Analysis of Efficacy Against Human Papillomavirus Type 16 and 18—Related Cervical Intraepithelial Neoplasia Grade 2/3 and Adenocarcinoma In Situ
| Vaccine (N = 10,291) |
Placebo (N = 10,292) |
||||||
|---|---|---|---|---|---|---|---|
| n | Cases | Rate* | n | Cases | Rate* | Efficacy (95% CI) | |
| Per-protocol susceptible population† | |||||||
| HPV 16/18-related CIN 2/3 or AIS | 8579 | 1 | < .1 | 8550 | 85 | .4 | 99% (93–100) |
| By lesion type | |||||||
| CIN 2 | 8579 | 0 | 0 | 8550 | 56 | .3 | 100% (93–100) |
| CIN 3 | 8579 | 1 | < .1 | 8550 | 51 | .2 | 98% (89–100) |
| AIS | 8579 | 0 | 0 | 8550 | 7 | < .1 | 100% (31–100) |
| By HPV type | |||||||
| HPV 16-related | 7455 | 1 | < .1 | 7265 | 73 | .4 | 99% (92–100) |
| HPV 18-related | 7450 | 0 | 0 | 7381 | 18 | .1 | 100% (78–100) |
| Unrestricted susceptible population‡ | |||||||
| HPV 16/18-related CIN 2/3 or AIS | 9729 | 3 | < .1 | 9737 | 121 | .4 | 98% (93–100) |
| By lesion type | |||||||
| CIN 2 | 9729 | 1 | < .01 | 9737 | 77 | .3 | 99% (93–100) |
| CIN 3 | 9729 | 2 | < .01 | 9737 | 75 | .3 | 97% (90–100) |
| AIS | 9729 | 0 | 0 | 9737 | 10 | < .1 | 100% (55–100) |
| By HPV type | |||||||
| HPV 16-related | 8502 | 3 | < .1 | 8497 | 103 | .4 | 97% (91–99) |
| HPV 18-related | 8383 | 0 | 0 | 8410 | 25 | .1 | 100% (84–100) |
| ITT populations§ | |||||||
| HPV 16/18-related CIN 2/3 or AIS | 10,291 | 142 | .5 | 10,292 | 255 | .9 | 44% (31–55) |
| By lesion type | |||||||
| CIN 2 | 10,291 | 82 | .3 | 10,292 | 163 | .5 | 50% (34–62) |
| CIN 3 | 10,291 | 99 | .3 | 10,292 | 162 | .5 | 39% (21–53) |
| AIS | 10,291 | 6 | < .1 | 10,292 | 13 | < .1 | 54% (−30–86) |
| By HPV type | |||||||
| HPV 16-related | 10,291 | 134 | .5 | 10,292 | 232 | .8 | 42% (28–54) |
| HPV 18-related | 10,291 | 8 | < .1 | 10,292 | 42 | .2 | 81% (59–92) |
Each woman counted only once in each applicable row.
Cases per 100 person-years at risk.
Women with at least 1 follow-up visit post-dose 3: 8492 vaccine vs 8462 placebo for analysis of HPV 16/18 endpoints; 7401 vs 7203 for analysis of HPV 16 endpoints; 7381 vs 7314 for analysis of HPV 18 endpoints.
Women with at least 1 follow-up visit post—dose 1: 9348 vaccine vs 9406 for analysis of HPV 16/18 endpoints; 8165 vs 8200 for analysis of HPV 16 endpoints; 8151 vs 8209 for analysis of HPV 18 endpoints.
Women with at least 1 dose and had at least 1 follow-up visit post—dose 1: 9841 vaccine and 9904 placebo. 95% CI, 95% confidence interval; AIS, adenocarcinoma in situ; CIN, cervical intraepithelial neoplasia; HPV, human papillomavirus; N, number randomized to group; n = number in specified population.
Reprinted from The Lancet, Volume 369, Ault KA et al, “Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomized clinical trials,” pp. 1861–1868, Copyright 2007, with permission from Elsevier.