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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
Prof. Jan Prins, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT02087384
First received: March 7, 2014
Last updated: June 26, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention Phase
AIN
HIV
Biological: Gardasil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Quadrivalent HPV Vaccination After Effective Treatment of Anal Intraepithelial Neoplasia in HIV+ Men

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity/ safety of the Gardasil vaccine in HIV+ MSM. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    One week after each vaccination and during all follow up visits the most common adverse events of Gardasil and other eventually occuring complaints will be evaluated by history taking. Adverse events will be graded according to the CTCAE v4 (Common Terminology Criteria for Adverse Events), which grades events on a scale of 1 to 5, with higher grades indicating greater severity.

  • Recurrence of intra-anal or peri-anal HG AIN at the moment of last vaccination and 6 months afterwards. [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • Cumulative occurrence of intra-anal or peri-anal LG AIN at 12 months after the last vaccination. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The patients with LG AIN at inclusion are excluded from this analysis.

  • Cumulative occurrence of anogenital warts at 12 months after the last vaccination. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Evaluated by physical examination and history taking.

  • Causative HPV type in recurrent AIN lesions, as assessed by LCM/ PCR. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • HPV type-specific antibody response. [ Time Frame: 9 months (3 months after last vaccination) ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: March 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gardasil
Gardasil
Biological: Gardasil
Intramuscular Gardasil vaccination at 0, 2 and 6 months.
Other Names:
  • Quadrivalent HPV vaccine
  • Vaccine against HPV-6, 11, 16, 18
Placebo Comparator: Placebo
Intramuscular Saline 0.9% vaccination at 0, 2 and 6 months

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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]).
  • Pre-treatment haematology, and plasma ASAT, ALAT and creatinine levels compatible with study inclusion (maximum 6 weeks before screening visit).

Exclusion criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02087384

Contacts
Contact: Karien CM Gosens, MD 0031205662575 k.c.gosens@amc.nl
Contact: Jan M Prins, prof, MD, infectiologist 0031205664380 j.m.prins@amc.nl

Locations
Netherlands
Academic Medical Center Recruiting
Amsterdam, Noord-Holland, Netherlands, 1105 AZ
Contact: Karien CM Gosens, MD    0031205662575    k.c.gosens@amc.nl   
Sub-Investigator: Karien CM Gosens, MD         
Principal Investigator: Jan M Prins, MD, prof         
DC Klinieken Oud Zuid Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1071 NX
Contact: Arne van Eeden, MD    0031205730315    avaneeden@dcklinieken.nl   
Principal Investigator: Arne van Eeden, MD         
Onze Lieve Vrouwe Gasthuis Recruiting
Amsterdam, Noord-Holland, Netherlands, 1090 HM
Contact: Guido Berk van den, MD    0031205993503    g.e.l.vandenberk@olvg.nl   
Contact: Danielle Vos, research nurse    031205994294    d.vos@olvg.nl   
Principal Investigator: Guido van den Berk, MD         
Slotervaart Ziekenhuis Not yet recruiting
Amsterdam, Noord-Holland, Netherlands, 1006 BK
Contact: Saskia Vrouenraets, MD, PhD    0031205129333    saskia.vrouenraets@slz.nl   
Principal Investigator: Saskia Vrouenraets, MD, PhD         
Sponsors and Collaborators
Prof. Jan Prins
Investigators
Principal Investigator: 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)
  More Information

No publications provided

Responsible Party: Prof. Jan Prins, Professor. dr. J.M. Prins, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT02087384     History of Changes
Other Study ID Numbers: NL45200.018.13
Study First Received: March 7, 2014
Last Updated: June 26, 2015
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Anal intraepithelial neoplasia
HIV
HPV
Vaccination
Gardasil
Prophylactic

Additional relevant MeSH terms:
Carcinoma in Situ
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on August 03, 2015