Table 5.
Efficacy or effectiveness of vaccination against human papillomavirus in males: infections in participants irrespective of their HPV status at enrolment
| Study | Design | No. of events/no. of participants | Unadjusted estimate (95% CI) | Confounder-adjusted estimate (95% CI) | VE (95% CI) | |
|---|---|---|---|---|---|---|
| Vaccine | Control | |||||
| Incident anogenital infection | ||||||
| HPV 16 | ||||||
| Giuliano et al. 2011 [32]a | RCT | 189/4070.0 pyrs | 259/4014.2 pyrs | NR | NA | 28.0% (12.9–40.7%) |
| HPV 18 | ||||||
| Giuliano et al. 2011 [32]a | RCT | 89/4205.4 pyrs | 133/4151.5 pyrs | NR | NA | 33.9% (13.0–50.1%) |
| Persisting anogenital infection | ||||||
| HPV 16 | ||||||
| Giuliano et al. 2011 [32]a | RCT | 71/4199.5 pyrs | 131/4112.7 pyrs | NR | NA | 46.9% (28.6–60.8%) |
| HPV 18 | ||||||
| Giuliano et al. 2011 [32]a | RCT | 25/4267.0 pyrs | 56/4210.1 pyrs | NR | NA | 56.0% (28.8–73.7%) |
| Incident anal infection | ||||||
| HPV 16 | ||||||
| Palefsky et al. 2011 [33]a | RCT | 40/615.7 pyrs | 71/599.9 pyrs | NR | NA | 45.1% (18.0–63.7%) |
| HPV 18 | ||||||
| Palefsky et al. 2011 [33]a | RCT | 20/651.2 pyrs | 39/641.3 pyrs | NR | NA | 49.5% (11.3–72.1%) |
| Persisting anal infection | ||||||
| HPV 16 | ||||||
| Palefsky et al. 2011 [33]a | RCT | 24/636.6 pyrs | 51/622.3 pyrs | NR | NA | 54% (23.9–72.9%) |
| HPV 18 | ||||||
| Palefsky et al. 2011 [33]a | RCT | 7/668.4 pyrs | 26/656.3 pyrs | NR | NA | 73.6% (37.5–90.3%) |
| Incident oral infection | ||||||
| HPV 16 and/or HPV 18 | ||||||
| Kahn et al. 2015 [24]a | Cross-sectional study | 0/23 | 9/48 | NR | NR | 91% (−59–99.5%) |
| Persisting oral infection | ||||||
| NCT01461096 [26]b | RCT | 1/236 | 8/236 | 0.12 (0.02–0.98)c | NR | 88% (2–98%) |
NA not applicable, NR not reported, pyrs person-years, VE vaccine efficacy or effectiveness
aVE as reported in the primary study
bVE calculated from unadjusted estimate
cHazard ratio (95% CI)