Table 7 Efficacy or effectiveness of vaccination against human papillomavirus in males: anogenital lesions in participants irrespective of their HPV status at enrolment (corresponding to intention-to-treat analysis in RCTs)
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 | 24/4635.4 pyrs | 72/4558.8 pyrs | NR | NA | 67.2% (47.3–80.3%) |
  Coskuner et al. 2014 [31]b | RCT | 45/91 | 35/80 | 1.26 (0.69–2.30) | NR | −26% (− 130 to 31%) |
 Anal | ||||||
  Palefsky et al. 2011 [33]a | RCT | 13/651.3 pyrs | 31/664.2 pyrs | NR | NA | 57.2% (15.9–79.5%) |
  Swedish & Goldstone 2014 [34]d, e | Cohort study | 10/269.3 pyrs | 37/604.3 pyrs | 0.49 (0.24–0.98) | 0.45 (0.22–0.92) | 55% (8–78%) |
Anal intraepithelial neoplasia grade 2 | ||||||
 Palefsky et al. 2011 [33]a | RCT | 11/668 pyrs | 29/671.5 pyrs | NR | NA | 61.9% (21.4–82.8%) |
 Swedish et al. 2012 [25]c, e | Cohort study | 12/117.6 pyrs | 35/222.8 pyrs | 0.52 (0.27–1.0) | 0.50 (0.26–0.98) | 50% (2–74%) |
Anal intraepithelial neoplasia grade 3 | ||||||
 Palefsky et al. 2011 [33]a | RCT | 10/665.9 pyrs | 19/672.8 pyrs | NR | NA | 46.8% (−20 to 77.9%) |
Anal cancer | ||||||
 Palefsky et al. 2011 [33] | RCT | 0/678.4 pyrs | 0/694.8 pyrs | NR | NA | – |
Penile, perineal or perianal neoplasia grade 2 or 3 | ||||||
 Giuliano et al. 2011 [32]a | RCT | 3/4663.1 pyrs | 2/4628.6 pyrs | NR | NA | −48.9% (− 1682.6 to 82.9%) |
Penile, perineal or perianal cancer | ||||||
 Giuliano et al. 2011 [32] | RCT | 0/4670.6 pyrs | 0/4630.5 pyrs | NR | NA | – |