Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males

Phase 2

Completed

Conditions: Anal Cancer
Penile Cancer
Nonneoplastic Condition
Precancerous Condition

Interventions: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Other: laboratory biomarker analysis

Registration Number: NCT01209325

Lead Sponsor: AIDS Malignancy Consortium

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 149

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vaccination	laboratory biomarker analysis	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
Vaccination	quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.

Primary Outcome Measures

Name	Time	Method
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA	Post Month 7 through Month 24	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.
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA	Post Month 7 through Month 24	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.
Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants	Post month 7 through month 24	Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA	Post Month 7 through Month 24	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.
Incidence of Persistent Anogenital Infection With HPV 6 DNA	Post Month 7 through Month 24	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.
Incidence of Persistent Anogenital Infection With HPV 16 DNA	Post Month 7 through Month 24	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.
Incidence of Persistent Anogenital Infection With HPV 18 DNA	Post Month 7 through Month 24	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.
Incidence of Persistent Anogenital Infection With HPV 11 DNA	Post Month 7 through Month 24	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.
Incidence of HGAIN Associated With HPV 6	Post month 7 through month 24	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.
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA	Post Month 7 through Month 24	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.
Incidence of HGAIN Associated With HPV 11	Post month 7 through month 24	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.
Incidence of HGAIN Associated With HPV 16	Post month 7 through month 24	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.
Incidence of HGAIN Associated With HPV 18	Post month 7 through month 24	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.
Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants	Post month 7 through month 24	Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants	Post month 7 through month 24	Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants	Post month 7 through month 24	Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers for HPV 11	Baseline through month 24	Geometric mean concentration of antibodies for HPV 11 at each visit
Geometric Mean Titers for HPV 16	Baseline through 24 months	Geometric mean concentration of antibodies for HPV 16 at each visit
Geometric Mean Titers for HPV 18	Baseline through 24 months	Geometric mean concentration of antibodies for HPV 18 at each visit
Geometric Mean Titers for HPV 6	Baseline through month 24	Geometric mean concentration of antibodies for HPV 6 at each visit
Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine	Through Month 24	Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level	at 7 and 24 Months	Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level	at 7 and 24 Months	Geometric mean concentration of antibodies for HPV 6 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	at 7 and 24 Months	Geometric mean concentration of antibodies for HPV 11 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	at 7 and 24 Months	Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months

Trial Locations

Locations (18): UCLA Clinical AIDS Research and Education (CARE) Center
🇺🇸
Los Angeles, California, United States
Ruth M. Rothstein Core Center at Cook County Hospital
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Chicago, Illinois, United States
Laser Surgery Care
🇺🇸
New York, New York, United States
Washington University School of Medicine
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Saint Louis, Missouri, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
John H. Stroger, Jr. Hospital of Cook County
🇺🇸
Chicago, Illinois, United States
Moores UCSD Cancer Center
🇺🇸
La Jolla, California, United States
Childrens Hospital Los Angeles
🇺🇸
Los Angeles, California, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸
Aurora, Colorado, United States
Fenway Community Health
🇺🇸
Boston, Massachusetts, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸
San Francisco, California, United States
Boston University Cancer Research Center
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Boston, Massachusetts, United States
Virginia Mason Medical Center
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Seattle, Washington, United States
St. Jude's Children's Research Hospital
🇺🇸
Memphis, Tennessee, United States
Thomas Street Health Center
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Houston, Texas, United States
University of Puerto Rico Comprehensive Cancer Center
🇵🇷
San Juan, Puerto Rico
Dan L. Duncan Cancer Center at Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Montefiore Medical Center
🇺🇸
Bronx, New York, United States