drugset / Trial / NCT01923116
Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia
Phase 1/2
Completed
40 enrolled
Academic Medical Center - University of Amsterdam
ISA Pharmaceuticals B.V. · collabLeiden University Medical Center · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-08
- Primary completion
- 2017-06
- Completion
- 2017-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2b | Protein / enzyme biologic | 1 ug/kg | Subcutaneous |
| Subject | SLP-HPV-01® | Vaccine | 10 ug | Other |
| Subject | SLP-HPV-01® | Vaccine | 20 ug | Other |
| Subject | SLP-HPV-01® | Vaccine | 40 ug | Other |