HPV (Human Papilloma Virus) Vaccination After Treatment of Anal Intraepithelial Neoplasia (AIN)

• Status: Completed
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex with men) who were successfully treated for high grade AIN.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Jan Prins
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Written informed consent.

• Age ≥ 18 years.

• HIV+ MSM, CD4 count > 350/ul (maximum 6 months before screening visit).

• Biopsy-proven intra-anal high-grade AIN successfully treated in the past year with cauterization, cryotherapy, Efudix, imiquimod or another form of local treatment. A maximum interval of 1 year between last treatment and first vaccination is allowed. Lesions with regression from HG to LG AIN (AIN 1) will also be eligible.

• Lesions (still) in remission:

• Remission has to be established by 2 independent HRA anoscopists.

• A maximum interval of 3 months is allowed between the first of these HRAs and the first vaccination, and a maximum interval of 6 weeks is allowed between the second of these HRAs and the first vaccination.

• Biopsies of suspect lesions need to be obtained in one of the HRA sessions.

• Good performance status (a Karnofsky performance score of ≥ 60 [on a scale of 0 to 100, with higher scores indicating better performance status]).

• Pre-treatment haematology, and plasma ASAT, ALAT and creatinine levels compatible with study inclusion (maximum 6 weeks before screening visit).

Exclusion criteria:

• Immunosuppressive medication or other diseases associated with immunodeficiency.

• Life expectancy less than one year.

• Previous HPV vaccination.

• History of anal cancer.

• Other diseases not compatible with study participation.

• Allergy against constituent of Gardasil ® vaccine.

• Currently peri-anal AIN2 or 3.