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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54737

Enrollment

750

Registered

2019-02-13

Start date

2019-10-17

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

cervical intra-epithelial neoplasia precursor of cervical cancer

Interventions

Intervention: 0.5 ml nonavalent HPV vaccination. Comparator: placebo vaccination. Dosing scheme: preferable at day of LEEP(or within 4 weeks), at 2 and 6 month follow-up visits. The syringes of the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Women 18 years or older - Histologically proven CIN II or III - Patients treated with LEEP (inclusion within 4 weeks after LEEP)

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
Primary outcome Recurrence of CIN II-III after 24 months	—

Secondary

Measure	Time frame
Secondary outcome 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	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)