TABLE 1.
Author, year, country | Study design | Age of participants | Number of participants | Study population | Intervention | Follow‐up | HPV genotyping | Main results | Comments |
---|---|---|---|---|---|---|---|---|---|
Karimi‐Zarchi et al., 2020, Iran 28 | Randomized controlled trial | 21–45 years |
312: 154 in control group and 158 in vaccination group |
Women treated for histologically confirmed residual/recurrent CIN1 or CIN2 or CIN3 | Three doses of the quadrivalent HPV vaccine. Women were excluded if they received only one dose | 2 years | No |
Vaccine efficacy: CIN1: 54.9%. CIN2: 63.3%. CIN3: 52.3% Total for CIN1‐3: 58.7% |
Vaccine efficacy measured as difference in attack rate between vaccinated and nonvaccinated. The study did not distinguish between recurrent and residual disease |
Pieralli et al., 2018, Italy 29 | Randomized controlled trial | Under 45 years of age |
178: 89 in control group and 89 in vaccination group |
Women treated for CIN, any grade | Three doses of the quadrivalent HPV vaccine | At least 3 years | HPV genotyping if recurrence occurred. No HPV status of primary lesion available | Recurrence of LSIL/HSIL (in cervix, vulva and vagina) was 3.4% in vaccinated group vs 13.5% in the nonvaccinated group | Persistent disease 3 months after treatment was an exclusion criterion |
Ghelardi et al., 2018, Italy 13 | Observational study | 18–45 years |
524: 276 in control group and 248 in vaccination group |
Women treated with LEEP for histologically confirmed CIN2+ or cervical cancer stage IA1 | Three doses of the quadrivalent HPV vaccine. | Median 36 months (range 6–48 months) | HPV test and genotyping during the follow‐up program | Risk reduction of 81.2% (95% CI 34.3–95.7) in recurrence of CIN2+ |
CIN2+ independent of HPV type. Persistent histologically confirmed disease at 6‐month follow‐up visit was an exclusion criterion |
Kang et al., 2013, Korea 12 | Observational study | 20–45 years |
737: 377 in control group and 360 in vaccination group |
Women treated with LEEP for CIN2–3 | Three doses of the quadrivalent HPV vaccine | Median 3.5 years | Before LEEP and at every visit after LEEP HPV DNA test was performed | Hazard ratio of risk of recurrence of CIN2‐3 in women not receiving the vaccine vs women receiving the vaccine: 2.84 (1335–6042) P < 0.01 | CIN2 or CIN3 at 3‐month follow‐up visit was considered as residual disease and patients were excluded |
Sand et al., 2019, Denmark 14 | Observational study | 17–51 years |
17 128 women: 15 054 in control group and 2074 in vaccination group, of which 399 were vaccinated 0–3 months before excisional treatment and 1675 were vaccinated 0–12 months after excisional treatment |
Women treated with excisional treatment for CIN3 | HPV vaccination (not further specified) | At least 3 years | No | Adjusted hazard ratio of risk of recurrent CIN2+ in women vaccinated 0–12 months after excisional treatment: 0,88 (95% CI 0.67–1.14) | Follow‐up began 1‐year post‐treatment to ensure only women with recurrent and not residual disease were included in the analysis |
Ortega‐Quinonero et al., 2018, Spain 30 | Observational study | 18–65 years |
242: 139 in control group and 103 in vaccination group |
Women treated with LEEP for CIN2–3 | Bivalent or quadrivalent HPV vaccination, number of doses not specified | 2 years | HPV testing and determination of genotype both before treatment and during follow‐up | Recurrence of CIN2‐3 in vaccinated group was 4.8% vs 15.8% in the nonvaccinated | Residual disease, defined as a histological diagnosis of CIN2‐3 in biopsies three months after LEEP, was an exclusion criterion |
Petrillo et al., 2020, Italy 31 | Observational study | 32–47 years |
285: 103 in control group and 182 in vaccination group |
Women treated with LEEP due to CIN. | Bi‐ or quadrivalent HPV vaccination, number of doses not specified | 2 years | HPV testing before treatment, but not systematically at time of relapse | Odds ratio of disease recurrence: 0.4 (95% CI 0.2–0.8, P = 0,02) in vaccinated vs nonvaccinated |
Outcome was defined as a cervical lesion of any histologic type (CIN1–3). No distinction between recurrent and residual disease |
del Pino et al., 2020, Spain 32 | Observational study | 26–64 years |
265. 112 in control group. 153 in vaccination group |
Women treated with excisional treatment for CIN | Three doses of the bi‐, quadri‐ or nonavalent HPV vaccine. Women who received less than three doses were not excluded | At least 2 years | HPV testing both at enrolment and during follow‐up | Adjusted odds ratio of persistent/recurrent HSIL: 0.2 (95% CI 0.1–0.7) in vaccinated vs nonvaccinated | No distinction between residual and recurrent disease was made. 42.3% of the women showed either HSIL or LSIL at the first post‐treatment visit after 6 months |
Bogani et al, 2020, Italy 33 | Observational study. | 24–44 years |
300 in the propensity score‐matched comparison. 200 in control group. 100 in vaccination group |
Women treated with LEEP for CIN2 or CIN3 | Three doses of the bi‐ or quadrivalent HPV vaccine. Women who received less than three doses were not excluded | 5 years | HPV testing before and after treatment. No information on HPV type was not an exclusion criterion | Recurrence of HSIL in vaccinated group was 0% vs 4,5% (n = 9) in control group. Not statistically significant. | No information on whether women in control group had previously received the HPV vaccine. Differentiation between residual and recurrent disease in the statistical analysis |
Abbreviations: CIN, cervical intraepithelial lesion; HPV, human papillomavirus; HSIL, high‐grade squamous intraepithelial lesion; LEEP, loop electrosurgical excision procedure; LSIL, low‐grade squamous intraepithelial lesion.