anal intraepithelial neoplasia
Conditions
Interventions
Patients will be vaccinated 3 or 4 times with a 3-week interval with the
SLP-HPV-01® vaccine.
High-resolution anoscopy (HRA) will be performed at inclusion, and repeated at
3, 6,12 and 18 months. T
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: • Immunosuppressive medication or other diseases associated with immunodeficiency • Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical end points will be both toxicity/ safety, and the regression of the lesions at 3,6 and 12 months, as assessed by HRA, with biopsies taken of the lesion sites. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are regression of lesions at 18 months and HPV16-specific immunity in blood will be measured: i.e. ELISPOT (IFNg) for ex-vivo detection of antigen-specific responses and multiparametric intracellular cytokine/extracellular activation marker staining to determine the type (CD4+ and/or CD8+) and function (activation status and/or cytokines) of T-cells that respond. | — |
Countries
Netherlands
Outcome results
None listed