Therapeutic Vaccination against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Me

Phase 2

Completed

• Conditions: anal intraepithelial neoplasia; 10047438; 10017991

• Registration Number: NL-OMON41467
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

• HIV+, CD4 count > 350/ul,
• Biopsy-proven intra-anal high-grade AIN caused by HPV16, resistant to, or recurring after previous treatment with cauterization, 5FU or imiquimod. A patient is considered resistant to cauterization if after 2 cauterization sessions still lesions are found. A patient is considered resistant to 5FU or imiquimod if after 4 months of weekly (multiple day) application still lesions are found.
• 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 as described previously

Exclusion Criteria

• Immunosuppressive medication or other diseases associated with immunodeficiency
• Life expectancy < 1 year
• History of anal carcinoma
• IFN-a criteria (see SmPC): severe cardiac, thyroid, hepatic or central nervous system disease, including severe depression in the past.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical end points will be both toxicity/ safety, and the<br /><br>regression of the lesions at 3,6 and 12 months, as assessed by HRA, with<br /><br>biopsies taken of the lesion sites. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are regression of lesions at 18 months and HPV16-specific<br /><br>immunity in blood will be measured: i.e. ELISPOT (IFNg) for ex-vivo detection<br /><br>of antigen-specific responses and multiparametric intracellular<br /><br>cytokine/extracellular activation marker staining to determine the type (CD4+<br /><br>and/or CD8+) and function (activation status and/or cytokines) of T-cells that<br /><br>respond. </p><br>