Clinical trial · Interventional
Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia
Therapeutic Vaccination Against Human Papillomavirus Type 16 for the Treatment of Anal Intraepithelial Neoplasia in HIV+ Men
NCT01923116CI-TRIAL-00032101VACCAIN-TcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective of the study is to assess, in a phase 1/2 study, the safety and efficacy of this synthetic vaccine SLP-HPV-01® in HIV+ men with CD4 counts \> 350 x 10E6/l and HPV16-induced intra-anal high-grade AIN (grade 2-3) that failed on, or recurred after previous treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Intraepithelial Neoplasia | Anal Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| HIV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV-16 vaccine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV-16 vaccine
- interventionNames
- Drug: HPV-16 vaccine
Primary outcomes (1)
- measure
- Safety/ toxicity of the HPV-16 vaccine in HIV+ MSM
- timeFrame
- up to 18 months
- description
- Monitoring for spontaneous adverse events and injection-site reactions will be done weekly for three weeks after each vaccination. Clinical assessments and laboratory tests (routine hematology and chemistry) will be performed before the second and third vaccination and thereafter every 3 months for a total of 18 months of follow-up. Adverse events are graded according to version 3.0 of the Common Terminology Criteria for Adverse Events (CTCAE), which grades events on a scale of 1 to 5, with higher grades indicating greater severity.
Secondary outcomes (1)
- measure
- Regression of intra-anal high grade AIN lesion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Age ≥ 18 years * HIV+ MSM, CD4 count \> 350/ul (maximum 3 months before screening visit) * Biopsy-proven intra-anal high-grade AIN caused by HPV16, resistant to, or recurring after previous treatment with cauterization (or other local treatment), 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. This means: Leukocytes \>3 x 109/L, lymfocytes \>1 x 109/L, trombocytes \>100 x 109/L and hematocrit \>30%. Exclusion Criteria: * Immunosuppressive medication or other diseases associated with immunodeficiency * Life expectancy \< 1 year * History of anal carcinoma * IFN-α criteria (see SmPC): severe cardiac, thyroid, hepatic or central nervous system disease, including severe depression in the past. * Previous HPV vaccination * Currently treated with IFN-α against hepatitis C
References
Publications (0)
Data not yet available
No reference posted for this study.