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

NCT01209325 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: AMC-072U01CA121947CDR0000685816
• Study Type: interventional
• Target: 149
• Locations: 2 countries
• Sites: 19

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.

Conditions

Anal Cancer; Nonneoplastic Condition; Penile Cancer; Precancerous Condition

Keywords

human papilloma virus infection; anal cancer; penile cancer; HIV infection

Outcome Measures

Primary Outcomes (16)

• Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA

  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.

  Post Month 7 through Month 24

• Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA

  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.

  Post Month 7 through Month 24

• Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA

  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.

  Post Month 7 through Month 24

• Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA

  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.

  Post Month 7 through Month 24

• Incidence of Persistent Anogenital Infection With HPV 6 DNA

  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.

  Post Month 7 through Month 24

• Incidence of Persistent Anogenital Infection With HPV 11 DNA

  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.

  Post Month 7 through Month 24

• Incidence of Persistent Anogenital Infection With HPV 16 DNA

  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.

  Post Month 7 through Month 24

• Incidence of Persistent Anogenital Infection With HPV 18 DNA

  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.

  Post Month 7 through Month 24

• Incidence of HGAIN Associated With HPV 6

  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.

  Post month 7 through month 24

• Incidence of HGAIN Associated With HPV 11

  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.

  Post month 7 through month 24

• Incidence of HGAIN Associated With HPV 16

  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.

  Post month 7 through month 24

• Incidence of HGAIN Associated With HPV 18

  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.

  Post month 7 through month 24

• Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants

  Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

  Post month 7 through month 24

• Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants

  Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

  Post month 7 through month 24

• Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants

  Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

  Post month 7 through month 24

• Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants

  Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

  Post month 7 through month 24

Secondary Outcomes (9)

• Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine

  Through Month 24

• Geometric Mean Titers for HPV 6

  Baseline through month 24

• Geometric Mean Titers for HPV 11

  Baseline through month 24

• Geometric Mean Titers for HPV 16

  Baseline through 24 months

• Geometric Mean Titers for HPV 18

  Baseline through 24 months

Study Arms (1)

Vaccination

EXPERIMENTAL

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

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

Interventions

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

Vaccination

laboratory biomarker analysis OTHER

Vaccination

Eligibility Criteria

• Age: 13 Years - 26 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator
• University of Arkansas: collaborator
• Merck Sharp & Dohme LLC: collaborator
• AIDS and Cancer Specimen Resource: collaborator

Study Sites (19)

Moores UCSD Cancer Center

La Jolla, California, 92093, United States

Location

UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, 90024, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Colorado Cancer Center at UC Health Sciences Center

Aurora, Colorado, 80045, United States

Location

John H. Stroger, Jr. Hospital of Cook County

Chicago, Illinois, 60612-9985, United States

Location

Ruth M. Rothstein Core Center at Cook County Hospital

Chicago, Illinois, 60612, United States

Location

Fenway Community Health

Boston, Massachusetts, 02115, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Laser Surgery Care

New York, New York, 10010, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

St. Jude's Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Thomas Street Health Center

Houston, Texas, 77009, United States

Location

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Puerto Rico Comprehensive Cancer Center

San Juan, 00927, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 30658128 DERIVED

MeSH Terms

Conditions

Anus Neoplasms; Penile Neoplasms; Precancerous Conditions; Papillomavirus Infections; HIV Infections

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Penile Diseases; Male Urogenital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Dr. Joel M. Palefsky
• Organization: University of California, San Francisco

jpalefsky@medicine.ucsf.edu

415-476-1574

Study Officials

• Joel Palefsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2010
• First Posted: September 27, 2010
• Study Start: June 28, 2011
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2017
• Last Updated: August 11, 2020
• Results First Posted: May 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (18)