VACCIN study

Cervical cancer is preceded by precursor stages: Cervical Intraepithelial Neoplasia, (CIN). These CIN abnormalities are caused by the Human Papilloma virus (HPV) and are mostly found in women in their reproductive age. There is an effective prophylactic vaccine against HPV, given since 2009 in the Netherlands to girls of 12 and 13 years old. This vaccine is very effective against the occurrence of CIN abnormalities in this group. Also, in older women who already had an HPV infection, without CIN abnormalities, the vaccine has shown to be effectively for preventing to develop CIN. The current treatment of CIN II-III (moderate to severe precursor stages) is surgical removal of a part of the cervix, called a Loop Electrosurgical Excision Procedure (LEEP). The recurrence rate or residual rate of a LEEP is up to 17%. A secondary surgical treatment is necessary in these women. Surgical treatments are associated with bleeding, narrowing of the cervix and infection. The biggest problem, with sometimes lifelong consequences, are the obstetric complications, especially premature birth. This becomes more frequent and more serious after repeated surgical intervention. The (repeated) treatment is also a burden of the women and her relatives. There is limited data that shows that prophylactic HPV vaccination after LEEP reduces the chance of recurrence, therefore leading to a reduction in repeated surgical interventions. There are no randomised controlled studies supporting this data.

Objectives:
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.

Study design:
Randomised, double blinded, placebo controlled trial in female patients with CIN II-III and treated with LEEP.

Study population:
The study population exists of adult female patients, diagnosed with (histologically proven) CIN II-III and treated with LEEP and no prior vaccination for HPV.

Intervention:
Three times a 0.5 ml nonavalent HPV vaccination. Comparator: placebo vaccination.

Main study parameters:
Primary outcome: CIN II-III at 24 months
Secondary: high risk HPV presence, cytology, number of re-interventions, cost-effectivity, adverse events, and quality of life.

HPV vaccination after LEEP for CIN reduces recurrence.

September 2019 start inclusion
All inclusions within 24 months.
Follow-up 24 months.

Intervention: Three times a 0.5 ml nonavalent HPV vaccination after LEEP
Comparator: placebo vaccination after LEEP
(Time of intervention: at time of LEEP, at 2 months and 6 months)