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HPV (Human Papilloma Virus) Vaccination After Treatment of Anal Intraepithelial Neoplasia (AIN)

NCT02087384 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2021-03-05

No results posted yet for this study

Summary

This study evaluates vaccination with the quadrivalent HPV vaccine (Gardasil) versus placebo vaccination on prevention of high grade AIN recurrence in HIV-positive MSM (men who have sex with men) who were successfully treated for high grade AIN.

Conditions

Interventions

BIOLOGICAL

Gardasil

Intramuscular Gardasil vaccination at 0, 2 and 6 months.

DRUG

Placebo

injection of 0.9% saline

Sponsors & Collaborators

  • Prof. Jan Prins

    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
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2018-07-31
Completion
2019-02-28

Countries

  • Netherlands

Study Locations

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Entities

Drugs
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 NCT02087384 on ClinicalTrials.gov