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

NCT ID: NCT01209325

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-28
• Study Completion Date: 2017-12-12

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.

Conditions

Anal Cancer; Nonneoplastic Condition; Penile Cancer; Precancerous Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Vaccination

Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.

Group Type: EXPERIMENTAL

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Intervention Type: OTHER

Interventions

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Intervention Type: BIOLOGICAL

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Men with a history of at least one male sexual partner

• "Men" is defined as those documented "male" at birth (including male-to-female transgendered persons)
• HIV-1 infection as documented by any federally approved, licensed HIV test performed in conjunction with screening (ELISA, western blot, or other approved test)

• Alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests
• Meets one of the following sets of criteria:

• Patients receiving antiretroviral therapy:

• Receipt of antiretroviral therapy for at least 3 months prior to entry
• No change in antiretroviral therapy within 30 days prior to entry
• Patients not receiving antiretroviral therapy:

• CD4-cell count ≥ 350 cells/mm³ within 90 days prior to study entry
• No plans to start antiretroviral therapy prior to Week 28
• Normal anal cytological result, LSIL/condyloma, or ASCUS result within 90 days prior to entry, and no HGAIN on biopsy

• No current or history of anal or peri-anal carcinoma
• No anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
• No presence of penile or scrotal condyloma, LGAIN (condyloma or AIN 1), HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry on biopsy
• No history of HGAIN

PATIENT CHARACTERISTICS:

• Karnofsky performance score ≥ 70 within 45 days prior to entry
• Absolute neutrophil count (ANC) > 750 cells/mm^3
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm^3
• AST (SGOT), ALT (SGPT) ≤ 3 times upper limit of normal (ULN)
• Total or conjugated (direct) bilirubin ≤ 2.5 times ULN within 45 days before study entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
• Calculated creatinine clearance ≥ 60 mL/min
• No hemophilia
• No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
• No serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
• No serious medical or psychiatric illness that, in the opinion of the site Investigator, will interfere with the ability of the subject to give informed consent or adhere to the protocol
• No allergy to yeast or any of the components of Gardasil

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior splenectomy
• No prior receipt of Gardasil or other HPV vaccine
• No use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
• No expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup

• No patients with hepatitis C who expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
• Not currently receiving anticoagulation therapy other than acetylsalicylic acid

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

AIDS and Cancer Specimen Resource

OTHER

Sponsor Role: collaborator

AIDS Malignancy Consortium

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel Palefsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Moores UCSD Cancer Center

La Jolla, California, United States

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

Laser Surgery Care

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

St. Jude's Children's Research Hospital

Memphis, Tennessee, United States

Thomas Street Health Center

Houston, Texas, United States

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

University of Puerto Rico Comprehensive Cancer Center

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

Kahn JA, Belzer M, Chi X, Lee J, Gaur AH, Mayer K, Martinez J, Futterman DC, Stier EA, Paul ME, Chiao EY, Reirden D, Goldstone SE, Ortiz Martinez AP, Cachay ER, Barroso LF, Da Costa M, Wilson CM, Palefsky JM; AIDS Malignancy Consortium and Adolescent Medicine Trials Network for HIV/AIDS Interventions. Pre-vaccination prevalence of anogenital and oral human papillomavirus in young HIV-infected men who have sex with men. Papillomavirus Res. 2019 Jun;7:52-61. doi: 10.1016/j.pvr.2019.01.002. Epub 2019 Jan 15.

Reference Type: DERIVED

PMID: 30658128 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

AMC-072

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA121947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000685816

Identifier Type: OTHER

Identifier Source: secondary_id

AMC-072

Identifier Type: -

Identifier Source: org_study_id