Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

December 1, 2023

Primary Completion Date

December 1, 2028

Study Completion Date

December 1, 2030

Conditions
Vulvar HSILHPV
Interventions
DRUG

Gardasil 9 Suspension for Injection

"After randomisation in the Gardasil arm, women will receive 3 Gardasil vaccinations~1. First injection: preferable at time of start treatment (imiquimod, lase or surgery). Window 4 weeks prior to treatment start (because surgical treatment can be postponed for logistical reasons) and 4 weeks after start treatment.~2. Second injection: should be administered at least 1 month after the first injection and 3 months before the third injection.~3. Third injection should be administered at 3 months after second injection. All injections should be administered within 1 year."

DRUG

Placebo

"After randomisation in the PLacebo arm, women will receive 3 Placebo vaccination with NaCl 0.9%~1. First injection: preferable at time of start treatment (imiquimod, lase or surgery). Window 4 weeks prior to treatment start (because surgical treatment can be postponed for logistical reasons) and 4 weeks after start treatment.~2. Second injection: should be administered at least 1 month after the first injection and 3 months before the third injection.~3. Third injection should be administered at 3 months after second injection. All injections should be administered within 1 year."

Trial Locations (1)

Unknown

Erasmus MC, Rotterdam

Sponsors
All Listed Sponsors
collaborator

Dutch Cancer Society

OTHER

lead

Erasmus Medical Center

OTHER