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.
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.
Moores UCSD Cancer Center
La Jolla, California, United States
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.
Time frame: Post Month 7 through Month 24
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 11 positive DNA in participants without HPV-11 related AIN at baseline.
Time frame: Post Month 7 through Month 24
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 16 positive DNA in participants without HPV-16 related AIN at baseline.
Time frame: Post Month 7 through Month 24
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA
Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 18 positive DNA in participants without HPV-18 related AIN at baseline.
Time frame: Post Month 7 through Month 24
Incidence of Persistent Anogenital Infection With HPV 6 DNA
Incident events are defined as having HPV 6 positive PCR results at 2 or more consecutive visits in those who were DNA negative for HPV 6. Persistence was defined based on being persistent in the same anatomical site.
Time frame: Post Month 7 through Month 24
Incidence of Persistent Anogenital Infection With HPV 11 DNA
Incident events are defined as having positive PCR results with HPV 11 at 2 or more consecutive visits in those who were DNA negative for HPV 11 at baseline. Persistence was defined based on being persistent in the same anatomical site.
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Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
149
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, United States
Ruth M. Rothstein Core Center at Cook County Hospital
Chicago, Illinois, United States
Fenway Community Health
Boston, Massachusetts, United States
Boston University Cancer Research Center
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
...and 9 more locations
Time frame: Post Month 7 through Month 24
Incidence of Persistent Anogenital Infection With HPV 16 DNA
Incident events are defined as having positive PCR results with HPV 16 at 2 or more consecutive visits in those who were DNA negative for HPV 16 at baseline. Persistence was defined based on being persistent in the same anatomical site.
Time frame: Post Month 7 through Month 24
Incidence of Persistent Anogenital Infection With HPV 18 DNA
Incident events are defined as having positive PCR results with HPV 18 at 2 or more consecutive visits in those who were DNA negative for HPV 18. Persistence was defined based on being persistent in the same anatomical site.
Time frame: Post Month 7 through Month 24
Incidence of HGAIN Associated With HPV 6
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 6 positive DNA in participants without HPV 6 related HGAIN at baseline.
Time frame: Post month 7 through month 24
Incidence of HGAIN Associated With HPV 11
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 11 positive DNA in participants without HPV 11 related HGAIN at baseline.
Time frame: Post month 7 through month 24
Incidence of HGAIN Associated With HPV 16
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 16 positive DNA in participants without HPV 16 related HGAIN at baseline.
Time frame: Post month 7 through month 24
Incidence of HGAIN Associated With HPV 18
Incident events are defined as having HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3) with HPV 18 positive DNA in participants without HPV 18 related HGAIN at baseline.
Time frame: Post month 7 through month 24
Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Time frame: Post month 7 through month 24
Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Time frame: Post month 7 through month 24
Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Time frame: Post month 7 through month 24
Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Time frame: Post month 7 through month 24
Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine
Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.
Time frame: Through Month 24
Geometric Mean Titers for HPV 6
Geometric mean concentration of antibodies for HPV 6 at each visit
Time frame: Baseline through month 24
Geometric Mean Titers for HPV 11
Geometric mean concentration of antibodies for HPV 11 at each visit
Time frame: Baseline through month 24
Geometric Mean Titers for HPV 16
Geometric mean concentration of antibodies for HPV 16 at each visit
Time frame: Baseline through 24 months
Geometric Mean Titers for HPV 18
Geometric mean concentration of antibodies for HPV 18 at each visit
Time frame: Baseline through 24 months
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 6 at 7 and 24 months
Time frame: at 7 and 24 Months
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 11 at 7 and 24 months
Time frame: at 7 and 24 Months
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months
Time frame: at 7 and 24 Months
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months
Time frame: at 7 and 24 Months