Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
Condition: Anal Cancer; Nonneoplastic Condition; Penile Cancer; Precancerous Condition
MeSH terms: Anus Neoplasms; Precancerous Conditions; Penile Neoplasms; Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective
      immune response to prevent viral infection.

      PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human
      papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing
           penile/scrotal condyloma and HPV-6, -11, -16, -18- associated perianal/anal disease in
           HIV-positive males who have sex with males (MSM) age 13-26 years by comparing the
           incidence of these lesions among those naïve to the relevant HPV type(s) at baseline to
           those who are not naïve at baseline.

        -  To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing
           persistent anogenital infection with HPV-6, -11, -16, or 18 in HIV-positive MSM age
           13-26 years by comparing the incidence of persistent infection among those naïve to the
           relevant HPV type(s) at baseline to those who are not naïve at baseline.

        -  To determine the protective effect of the HPV-6, -11, -16, -18 vaccine in preventing
           anogenital lesions associated with HPV 6,-11,-16, -18 and persistent infection with
           these types, in HIV-positive MSM age 13-26 years by comparing the incidence of lesions
           and persistent infection among those naïve to the relevant types at baseline to incident
           lesions and infection among MSM naïve to these HPV types who participated in the Merck
           020 protocol and who received placebo as part of the protocol.

      Secondary

        -  To define the safety of the HPV-6, -11, -16, -18 vaccine in HIV-positive MSM age 13-26
           years.

        -  To evaluate the levels and persistence of HPV 6, 11, 16 and 18 Ab titers after the
           vaccination series among subjects who are seropositive and seronegative at baseline.

        -  To examine whether the protective effect and antibody titers vary as a function of the
           following at the time of initial vaccination: subject age, HAART treatment status, HIV
           viral load, CD4 + T-cell count, and nadir CD4 level.

      Tertiary

        -  To quantify anogenital HPV DNA viral load prior to and after receipt of the quadrivalent
           HPV vaccine.

        -  To identify and quantify HPV types in the oral cavity of HIV-positive MSM prior to and
           after receipt of the quadrivalent HPV vaccine.

        -  To identify HPV strain variants among HIV-positive participants prior to and after
           receipt of the quadrivalent HPV vaccine.

        -  Assess the prevalence and incidence of urinary and gonorrhea and Chlamydia trachomatis
           infection at baseline and their relationship with prevalent and incident anogenital HPV
           infection and anal condyloma or AIN.

        -  To characterize young men's risk perceptions, sexual behaviors, and STI diagnosis after
           HPV vaccination.

      OUTLINE: This is a multicenter study.

      Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant
      vaccine intramuscularly on day 1 and in weeks 8 and 24.

      Blood and tissue samples may be collected periodically for laboratory studies.

      After completion of study treatment, patients are followed up for 2 years.
    

Intervention name(s): quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; laboratory biomarker analysis
Intervention type(s): Biological; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: human papilloma virus infection; anal cancer; penile cancer; HIV infection