11. Influence of the initial serological status on vaccine efficacy against cervical lesions associated with HPV16/18.
| Initial HPV DNA/ status |
Serology status |
Vaccine | Placebo |
Relative Risk (95% CI) |
Relative Risk ratio |
| FUTURE I trial (ph3,4v) (Garland 2007)* | |||||
| DNA(‐) | Sero‐ | 0/2,241 | 32/2258 | 0.00 (0.02 to 0.26) | 15.93 |
| Sero+ | 0/377 | 2/379 | 0.25 (0.01 to 5.20) | ||
| DNA(+) | Sero‐ | 27/232 | 31/213 | 0.80 (0.49 to 1.29) | 1.50 |
| Sero+ | 41/156 | 30/137 | 1.20 (0.80 to 1.81) | ||
| FUTURE II trial (ph3,4v) (FUTURE‐II 2007)** | |||||
| DNA(‐) | Sero‐ | 0/5,305 | 28/5260 | 0.02(0.00 to 0.14) | 7.41 |
| Sero+ | 0/498 | 4/524 | 0.13 (0.01 to 2.43) | ||
| DNA(+) | Sero‐ | 33/423 | 35/402 | 0.90 (0.57 to 1.41) | 1.12 |
| Sero+ | 47/298 | 52/332 | 1.01 (0.70 to 1.45 | ||
| PATRICIA trial (ph3,2v) (Paavonen 2009)** | |||||
| DNA(‐) | Sero‐ | 5/8709 | 92/8112 | 0.05 (0.02 to 0.12) | 6.16 |
| Sero+ | 3/1710 | 10/1777 | 0.31 (0.09 to 1.13) | ||
| DNA(+) | Sero‐ | 20/309 | 29/293 | 0.65 (0.38 to 1.13) | 1.70 |
| Sero+ | 53/333 | 44/307 | 1.11 (0.77 to 1.61) | ||
|
Pooled results for CIN2+ associated with HPV16/18 (FUTURE II trial (ph3,4v) and PATRICIA trial (ph3,2v)*** | |||||
| DNA(‐) | Sero‐ | 5/14,014 | 120/13,372 | 0.03 (0.02 to 0.09) | 5.85 (0.53 to 65.10) |
| Sero+ | 3/2205 | 14/2301 | 0.19 (0.09 t0 o.77) | ||
| DNA(+) | Sero‐ | 53/679 | 64/695 | 0.79 (0.60 to 1.05 | 1.37 (0.97 to 1.93) |
| Sero+ | 100/531 | 96/639 | 1.10 (0.88 to 1.36) | ||
*RR against HPV 6/11/16/18 related cervical lesions
** RR against HPV16/18 related CIN2+
*** Pooled only for FUTURE II and PATRIACIA, since, in the FUTURE I trial, the endpoints were cervical lesions and not CIN2+ associated with HPV16/18