Human papilloma virus (HPV) VACcination after surgical treatment of precursor lesions for cervical cancer.

Adjuvant vaccination against HPV in surgical treatment of CIN lesions, a Randomised Controlled Trial - VACCINstudy

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002764-94-NL

Enrollment

750

Registered

2019-02-13

Start date

2019-07-29

Completion date

Unknown

Last updated

2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human papilloma virus (HPV) causes cervical cancer. HPV vaccination is highly effective in primary prevention. There is less known about a possible secondary effect in women already infected with HPV. Our study proposes to investigate this efficacy in women with precursors of cervical cancer. HPV vaccination after surgical treatment to evaluate the efficacy to prevent recurrent disease. MedDRA version: 20.0 Level: LLT Classification code 10028986 Term: Neoplasm cervix System Organ Class: 10000

Interventions

Trade Name: Gardasil 9 Product Name: gardasil 9 Product Code: PRD4575517 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women 18 years or above Histologically proven CIN II or III Patients treated with LEEP Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 725 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: Prior HPV vaccination (Micro-) invasive carcinoma Immune-compromised patients Pregnancy Prior treatment for CIN-lesions Insufficient understanding of the Dutch language Women allergic to vaccine components

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate the efficacy of nonavalent HPV vaccination in women with a CIN lesion who will undergo or have undergone a LEEP in preventing recurrent CIN II-III after 24 months.;Secondary Objective: 1 Recurrence of CIN I-II-III at 6 and 24 months 2 The effect of treatments on HPV DNA presence 3 Pap-smear results 4 Number of LEEP 5 Cost-effectiveness analysis 6 Quality of life 7 Side effects and adverse events;Primary end point(s): Recurrence of CIN II-III after 24 months;Timepoint(s) of evaluation of this end point: 24 months after primary treatment. Follow-up is in accordance with the current follow-up protocol for CIN lesions. A negative hr-HPV test combined with a smear test outcome ‘Pap1’ are considered as normal (absence of dysplasia). The only part where this study deviates from the guideline is at our end point. When Pap smear or HPV test at 24 months is abnormal, a colposcopy will be performed and biopsies taken for histologic results. We choose this strategy to ensure an objective primary outcome with minimal invasive procedures.	—

Measure

Time frame

Main Objective: Evaluate the efficacy of nonavalent HPV vaccination in women with a CIN lesion who will undergo or have undergone a LEEP in preventing recurrent CIN II-III after 24 months.;Secondary Objective: 1 Recurrence of CIN I-II-III at 6 and 24 months 2 The effect of treatments on HPV DNA presence 3 Pap-smear results 4 Number of LEEP 5 Cost-effectiveness analysis 6 Quality of life 7 Side effects and adverse events;Primary end point(s): Recurrence of CIN II-III after 24 months;Timepoint(s) of evaluation of this end point: 24 months after primary treatment. Follow-up is in accordance with the current follow-up protocol for CIN lesions. A negative hr-HPV test combined with a smear test outcome ‘Pap1’ are considered as normal (absence of dysplasia). The only part where this study deviates from the guideline is at our end point. When Pap smear or HPV test at 24 months is abnormal, a colposcopy will be performed and biopsies taken for histologic results. We choose this strategy to ensure an objective primary outcome with minimal invasive procedures.

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Secondary

Measure	Time frame
Secondary end point(s): - Recurrence rate of CIN I-II-III after 6 and 24 months. - The effect of treatments on HPV DNA presence - PAP-smear results - Number of LEEP - Cost-effectiveness analysis - Quality of life - Side effects and adverse events;Timepoint(s) of evaluation of this end point: According to the Dutch guideline, the standard follow-up after treatment is 6 months and 24 months. After 2 months the second vaccination, QoL and questionnaire on social economic costs (iPCQ). After 6 months the last vaccination: cytology and HPV typing and QoL questionnaire. After 24 months, last visit: cytology and HPV testing QoL questionnaire.	—

Measure

Time frame

Secondary end point(s): - Recurrence rate of CIN I-II-III after 6 and 24 months. - The effect of treatments on HPV DNA presence - PAP-smear results - Number of LEEP - Cost-effectiveness analysis - Quality of life - Side effects and adverse events;Timepoint(s) of evaluation of this end point: According to the Dutch guideline, the standard follow-up after treatment is 6 months and 24 months. After 2 months the second vaccination, QoL and questionnaire on social economic costs (iPCQ). After 6 months the last vaccination: cytology and HPV typing and QoL questionnaire. After 24 months, last visit: cytology and HPV testing QoL questionnaire.

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Countries

Netherlands

Contacts

Public ContactDepartment of Gynaecologic Oncology

Erasmus MC

r.vandelaar@erasmusmc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026