AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Any incident of AIN or anal/perianal condyloma associated with HPV 16, 18, 6, or 11 DNA
Through Month 24
No
Joel Palefsky, MD
Principal Investigator
University of California, San Francisco
United States: Federal Government
CDR0000685816
NCT01209325
June 2011
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Childrens Hospital Los Angeles | Los Angeles, California 90027 |
UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco, California 94115 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
John H. Stroger, Jr. Hospital of Cook County | Chicago, Illinois 60612-9985 |
UCLA Clinical AIDS Research and Education (CARE) Center | Los Angeles, California 90024 |
Boston University Cancer Research Center | Boston, Massachusetts 02118 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Fenway Community Health | Boston, Massachusetts 02115 |
Dan L. Duncan Cancer Center at Baylor College of Medicine | Houston, Texas 77030 |
Laser Surgery Care | New York, New York 10011 |
Thomas Street Health Center | Houston, Texas 77009 |
Ruth M. Rothstein Core Center at Cook County Hospital | Chicago, Illinois 60612 |