Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: ISA Pharmaceuticals B.V.; Leiden University Medical Center
• Treatments: Vaccines

Criteria

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