Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia

NCT01923116 | Completed Phase 1 DMC

• 1 other identifier: NL42802.000.12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Intraepithelial Neoplasia; HIV

Keywords

Anal intraepithelial neoplasia; HIV; HPV; Vaccination; Treatment

Outcome Measures

Primary Outcomes (1)

• Safety/ toxicity of the HPV-16 vaccine in HIV+ MSM

  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.

  up to 18 months

Secondary Outcomes (1)

• Regression of intra-anal high grade AIN lesion

  Primary outcome: 3, 6, 12 months. Secondary: 18 months.

Other Outcomes (2)

• HPV16-specific immunity in blood

  3 weeks after the 1st, 2nd and 3rd vaccination

• Regression of peri-anal high grade AIN lesions

  3, 6, 12 and 18 months

Study Arms (1)

HPV-16 vaccine

EXPERIMENTAL

Drug: HPV-16 vaccine

Interventions

HPV-16 vaccine DRUG

Vaccination with SLP-HPV-01® with or without interferon-a injections.

HPV-16 vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Leiden University Medical Center: collaborator
• ISA Pharmaceuticals B.V.: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Study Officials

• Jan M Prins, prof, MD, infectiologist

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

• Henry JC de Vries, prof, MD, dermatologist

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. J.M. Prins

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 15, 2013
• Study Start: August 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

NL (1)