HPV vaccination after treatment of anal intraepithelial neoplasia
- Conditions
- Intra-anal high-grade anal intraepithelial neoplasia (AIN) (grade 2-3) in HIV+ men that was successfully treated in the past year with conventional cauterization, cryotherapy, or other forms of local treatment.MedDRA version: 14.1 Level: LLT Classification code 10059312 Term: Anal dysplasia System Organ Class: 100000004856Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2013-002009-70-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 125
• Written informed consent
• HIV+ MSM, CD4 count > 350/ul.
• Biopsy-proven intra-anal high-grade AIN successfully treated in the past year with cauterization, cryotherapy, Efudix, imiquimod or another form of local treatment. Lesions with regression from HG to Low grade (LG) AIN will also be eligible.
• Lesion (still) in remission at the moment of first vaccination (a maximum interval of 6 weeks between last HRA and first vaccination is allowed).
• Good performance status (a Karnofsky performance score of >= 60 [on a scale of 0 to 100, with higher scores indicating better performance status])
• Normal pretreatment laboratory blood values
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
• Immunosuppressive medication or other diseases associated with immunodeficiency
• Life expectancy less than one year
• Previous vaccination with the bivalent or quadrivalent HPV vaccine
• History of anal cancer
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method