NCT02087384

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

March 5, 2021

Status Verified

March 1, 2021

Enrollment Period

4.3 years

First QC Date

March 7, 2014

Last Update Submit

March 3, 2021

Conditions

AINHIV

Keywords

Anal intraepithelial neoplasiaHIVHPVVaccinationGardasilProphylactic

Outcome Measures

Primary Outcomes (1)

  • Cumulative recurrence of intra-anal or peri-anal HG AIN at 12 months after the last vaccination (18 months after inclusion), as assessed by HRA, with biopsies taken of suspect lesions.

    18 months

Secondary Outcomes (6)

  • Toxicity/ safety of the Gardasil vaccine in HIV+ MSM.

    18 months

  • Recurrence of intra-anal or peri-anal HG AIN at the moment of last vaccination and 6 months afterwards.

    6 and 12 months

  • Cumulative occurrence of intra-anal or peri-anal LG AIN at 12 months after the last vaccination.

    18 months

  • Cumulative occurrence of anogenital warts at 12 months after the last vaccination.

    18 months

  • Causative HPV type in recurrent AIN lesions, as assessed by LCM/ PCR.

    18 months

  • +1 more secondary outcomes

Study Arms (2)

Gardasil

EXPERIMENTAL

Gardasil

Biological: Gardasil

Placebo

PLACEBO COMPARATOR

Intramuscular Saline 0.9% vaccination at 0, 2 and 6 months

Drug: Placebo

Interventions

GardasilBIOLOGICAL

Intramuscular Gardasil vaccination at 0, 2 and 6 months.

Also known as: Quadrivalent HPV vaccine, Vaccine against HPV-6, 11, 16, 18
Gardasil
PlaceboDRUG

injection of 0.9% saline

Also known as: intramuscular Saline 0.9%
Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent.
  • Age ≥ 18 years.
  • HIV+ MSM, CD4 count \> 350/ul (maximum 6 months before screening visit).
  • Biopsy-proven intra-anal high-grade AIN successfully treated in the past year with cauterization, cryotherapy, Efudix, imiquimod or another form of local treatment. A maximum interval of 1 year between last treatment and first vaccination is allowed. Lesions with regression from HG to LG AIN (AIN 1) will also be eligible.
  • Lesions (still) in remission:
  • Remission has to be established by 2 independent HRA anoscopists.
  • A maximum interval of 3 months is allowed between the first of these HRAs and the first vaccination, and a maximum interval of 6 weeks is allowed between the second of these HRAs and the first vaccination.
  • Biopsies of suspect lesions need to be obtained in one of the HRA sessions.
  • Good performance status (a Karnofsky performance score of ≥ 60 \[on a scale of 0 to 100, with higher scores indicating better performance status\]).

You may not qualify if:

  • Immunosuppressive medication or other diseases associated with immunodeficiency.
  • Life expectancy less than one year.
  • Previous HPV vaccination.
  • History of anal cancer.
  • Other diseases not compatible with study participation.
  • Allergy against constituent of Gardasil ® vaccine.
  • Currently peri-anal AIN2 or 3.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

DC Klinieken Oud Zuid

Amsterdam, North Holland, 1071 NX, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1090 HM, Netherlands

Location

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, CombinedVaccinesBiological ProductsComplex MixturesPapillomavirus VaccinesViral Vaccines

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 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor. dr. J.M. Prins

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 14, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2018

Study Completion

February 1, 2019

Last Updated

March 5, 2021

Record last verified: 2021-03

Locations

NL(3)