Quadrivalent HPV vaccination after effective treatment of Anal Intraepithelial Neoplasia in HIV+ men (VACCAIN-P)

Phase 4

Completed

Conditions: 10047438
10017987
anal intraepithelial neoplasia

Registration Number: NL-OMON44810

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 125

Inclusion Criteria

• Written informed consent
• HIV+ males having sex with males (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

Exclusion Criteria

• 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 carcinoma

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Screening for AIN will be performed by high-resolution anoscopy (HRA), at<br /><br>inclusion (first vaccination) and at last vaccination (6 months), and repeated<br /><br>at 6 and 12 months after the last vaccination. Safety Monitoring for<br /><br>spontaneous adverse events and injection-site reactions will be performed one<br /><br>week after each vaccination and thereafter every 6 months for a total of 12<br /><br>months of follow-up.<br /><br><br /><br>Primary end point will be the cumulative recurrence of HG AIN at 12 months<br /><br>after the last vaccination, as assessed by HRA (High-Resolution Anoscopy), with<br /><br>biopsies taken of suspect lesions.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcome measures are toxicity/ safety, recurrence of HG AIN at last<br /><br>vaccination and 6 months afterwards, cumulative occurrence of LG AIN at 12<br /><br>months after the last vaccination, cumulative occurrence of anogenital warts at<br /><br>12 months after the last vaccination, causative HPV type in recurrent AIN<br /><br>lesions, as assessed by LCM (Laser Capture Microdissection)/ PCR (polymerase<br /><br>chain reaction), and HPV type-specific antibody response.</p><br>