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Therapeutic HPV-16 Vaccination for the Treatment of Anal Dysplasia

NCT01923116 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-03-15

No results posted yet for this study

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

Interventions

DRUG

HPV-16 vaccine

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

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER

  • ISA Pharmaceuticals B.V.

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Jan M Prins, prof, MD, infectiologist · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Henry JC de Vries, prof, MD, dermatologist · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2017-06-30
Completion
2017-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923116 on ClinicalTrials.gov