Clinical Trials Directory

Trials / Completed

CompletedNCT01209325

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

AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
149 (actual)
Sponsor
AIDS Malignancy Consortium · Network
Sex
Male
Age
13 Years – 26 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALquadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
OTHERlaboratory biomarker analysis

Timeline

Start date
2011-06-28
Primary completion
2017-12-12
Completion
2017-12-12
First posted
2010-09-27
Last updated
2020-08-11
Results posted
2020-05-27

Locations

19 sites across 2 countries: United States, Puerto Rico

Regulatory

Source: ClinicalTrials.gov record NCT01209325. Inclusion in this directory is not an endorsement.