Summary of findings 2. HPV vaccine effects on cervical lesions in adolescent girls and women negative for HPV16/18 DNA at baseline.
| HPV vaccine effects on cervical lesions in adolescent girls and women negative for HPV16/18 DNA at baseline | ||||||
| Patient or population: adolescent girls and women aged 15 to 45 years who were HPV16/18 negative before vaccination Setting: Europe, Asia Pacific countries, South & North America Intervention: HPV vaccines (at least one dose of bivalent or quadrivalent vaccines) Comparison: Placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with placebo | Risk with HPV vaccination1 | |||||
| Cervical cancer ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| CIN2+ associated with HPV16/18 Follow‐up (age 15 to 26 years): 1 to 8.5 years Follow‐up (age 24 to 45 years): 4 to 6 years |
15 to 26 years | RR 0.05 (0.03 to 0.10) | 34,478 (6 RCTs) | ⊕⊕⊕⊕ HIGH | ||
| 113 per 10,000 | 6 per 10,000 (3 to 11) | |||||
| 24 to 45 years | RR 0.30 (0.11 to 0.81) |
7552 (2 RCTs) |
⊕⊕⊕⊝ MODERATE 2 |
|||
| 45 per 10,000 | 14 per 10,000 (5 to 37) |
|||||
| CIN3+ associated with HPV16/18 (age 15 to 26 years) Follow‐up: 3 years |
57 per 10,000 | 3 per 10,000 (1 to 8) |
RR 0.05 (0.02 to 0.14) |
33,199 (3 studies) |
⊕⊕⊕⊕ HIGH | |
| AIS associated with HPV16/18 or 6/11/16/18 (age 15 to 26 years) Follow‐up: 3 years |
12 per 10,000 | 0 per 10,000 (0 to 8) | RR 0.09 (0.01 to 0.72) | 17,079 (2 RCTs) | ⊕⊕⊕⊝ MODERATE 2 |
Continuity correction |
| Any CIN2+ irrespective of HPV type (age 15 to 26 years) Follow‐up: 2 to 6.5 years |
231 per 10,000 | 95 per 10,000 (74 to 120) | RR 0.41 (0.32 to 0.52) | 19,143 (3 RCTs) | ⊕⊕⊕⊕ HIGH | |
| Any CIN3+ irrespective of HPV type ‐ not measured | ‐ | ‐ | ‐ | ‐ | ‐ | |
| Any AIS irrespective of HPV type ‐ not measured | ‐ | ‐ | ||||
| 1The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). Exception: when risk in vaccine group is zero, the 95% CI is computed using an exact binomial method.. AIS: adenocarcinoma in situ; CI: Confidence interval; CIN: cervical intraepithelial neoplasia; RR: Risk ratio | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Assumed risk calculated from the sum of control group event rates.
2 Downgraded due to serious imprecision in effect estimate (width 95% CI around RR > 0.6).