Anal Cancer Clinical Trial
Official title:
AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males
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.
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