Table 8.
Efficacy or effectiveness of vaccination against human papillomavirus in males: anogenital lesions in participants who were seronegative and PCR-negative at enrolment
| Study | Design | No. of events/no. of participants | Unadjusted estimate (95% CI) | Confounder-adjusted estimate (95% CI) | VE (95% CI) | |
|---|---|---|---|---|---|---|
| Vaccine | Control | |||||
| Condylomata acuminata | ||||||
| Genital | ||||||
| Giuliano et al. (2011) [32]a | RCT | 3/2830.9 pyrs | 28/2813.9 pyrs | NR | NA | 89.4% (65.5–97.9%) |
| Anal | ||||||
| Palefsky et al. (2011) [33]a | RCT | 0/386.8 pyrs | 6/418.2 pyrs | NR | NA | 100% (8.2–100%) |
| Anal intraepithelial neoplasia grade 2 | ||||||
| Palefsky et al. (2011) [33]a | RCT | 2/384.5 pyrs | 9/418.6 pyrs | NR | NA | 75.8% (−16.9 to 97.5%) |
| Anal intraepithelial neoplasia grade 3 | ||||||
| Palefsky et al. (2011) [33]a | RCT | 2/385.4 pyrs | 6/419.7 pyrs | NR | NA | 63.7 (−103 to 96.4%) |
| Anal cancer | ||||||
| Palefsky et al. (2011) [33] | RCT | 0/386.8 pyrs | 0/421.1 pyrs | NR | NA | – |
| Penile, perineal or perianal neoplasia grade 2 or 3 | ||||||
| Giuliano et al. (2011) [32]a | RCT | 0/2833.3 pyrs | 1/2824.7 pyrs | NR | NA | 100% (− 3788.2 to 100%) |
| Penile, perineal or perianal cancer | ||||||
| Giuliano et al. (2011) [32] | RCT | 0/2833.3 pyrs | 0/2826.2 pyrs | NR | NA | – |
NA not applicable, NR not reported, pyrs person-years, VE vaccine efficacy or effectiveness
aVE as reported in the primary study