Anal CancerPhase 2NCT01209325

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

A Phase 2 study testing quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine and laboratory biomarker analysis in people with Anal Cancer and Nonneoplastic Condition, run by AIDS Malignancy Consortium at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 13 to 26 years, men only
Conditions the study is for: Anal Cancer, Nonneoplastic Condition, Penile Cancer
What is being tested?: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine and laboratory biomarker analysis
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 149 participants
Where: 19 sitesin 2 countries
Study dates: 28 Jun 2011to 12 Dec 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 26 years
Men only
No healthy volunteers
Child, Adult

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

Trial locations and contacts

19 sites in 2 countries.

Country

City, postcode or hospital

19 sites in 2 countries

United States18 sites

University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, 80045
Fenway Community Health
Boston, Massachusetts, 02115
Boston University Cancer Research Center
Boston, Massachusetts, 02118
John H. Stroger, Jr. Hospital of Cook County
Chicago, Illinois, 60612-9985
Ruth M. Rothstein Core Center at Cook County Hospital
Chicago, Illinois, 60612
Thomas Street Health Center
Houston, Texas, 77009
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, 77030
Moores UCSD Cancer Center
La Jolla, California, 92093
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, 90024
Childrens Hospital Los Angeles
Los Angeles, California, 90027-0700
St. Jude's Children's Research Hospital
Memphis, Tennessee, 38105
Laser Surgery Care
New York, New York, 10010
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
Virginia Mason Medical Center
Seattle, Washington, 98101
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10461
Montefiore Medical Center
The Bronx, New York, 10467
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157

Other trials in United States

Puerto Rico1 site

University of Puerto Rico Comprehensive Cancer Center
San Juan, 00927

Other trials in Puerto Rico

About this study

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.

Read the 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
Being tested: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, laboratory biomarker analysis
Keywords: human papilloma virus infection, anal cancer, penile cancer, HIV infection
Medical subject headings: Anus Neoplasms, Penile Neoplasms, Precancerous Conditions, Papillomavirus Infections, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccineBiological
laboratory biomarker analysisOther

Study groups in NCT01209325
Study group	Role	What they receive
Vaccination	Experimental	Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24. Receives: Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Number of participants who experienced grade 3 and higher AEs that were possibly, probably or definitely related to the vaccine.
Measured: Through Month 24
Geometric Mean Titers for HPV 6
Geometric mean concentration of antibodies for HPV 6 at each visit
Measured: Baseline through month 24
Geometric Mean Titers for HPV 11
Geometric mean concentration of antibodies for HPV 11 at each visit
Measured: Baseline through month 24
Geometric Mean Titers for HPV 16
Geometric mean concentration of antibodies for HPV 16 at each visit
Measured: Baseline through 24 months
Geometric Mean Titers for HPV 18
Geometric mean concentration of antibodies for HPV 18 at each visit
Measured: Baseline through 24 months
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 6 at 7 and 24 months
Measured: at 7 and 24 Months
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 11 at 7 and 24 months
Measured: at 7 and 24 Months
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 16 at 7 and 24 months
Measured: at 7 and 24 Months
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Geometric mean concentration of antibodies for HPV 18 at 7 and 24 months
Measured: at 7 and 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 201112 Dec 2017

First posted27 Sep 2010 (estimated)
Study start28 Jun 2011
Primary completion12 Dec 2017
Study completion12 Dec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01209325
Sponsor's protocol ID: AMC-072
Other IDs: AMC-072, U01CA121947, CDR0000685816
Status last verified: Aug 2020
First submitted: 24 Sep 2010
Last updated: 11 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 30658128

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
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Localized Malignant Solid Neoplasm, Anal Cancer
Active, not recruitingPhase 2
Combination of Spartalizumab, mDCF and Radiotherapy in Patients With Metastatic Squamous Cell Anal Carcinoma
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All Anal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males
ClinicalTrials.gov ID: NCT01209325
Acronym / sponsor ID: AMC-072
Conditions: Anal Cancer, Nonneoplastic Condition, Penile Cancer, Precancerous Condition
Keywords: human papilloma virus infection, anal cancer, penile cancer, HIV infection
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 149 participants (actual)
Lead sponsor: AIDS Malignancy ConsortiumResearch network
Collaborators: National Cancer Institute (NCI), The Emmes Company, LLC, University of Arkansas, Merck Sharp & Dohme LLC, AIDS and Cancer Specimen Resource
Study start: 28 Jun 2011 (actual)
Primary completion: 12 Dec 2017 (actual)
Study completion: 12 Dec 2017 (actual)
First posted: 27 Sep 2010 (estimated)
Results: Posted 27 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Vaccination	Experimental	Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, Other: laboratory biomarker analysisGardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.

Who may qualify

Ages: 13 to 26 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child, Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine	Biological	Vaccination
laboratory biomarker analysis	Other	Vaccination

Primary outcome

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of Persistent Anogenital Infection With HPV 6 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of Persistent Anogenital Infection With HPV 11 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of Persistent Anogenital Infection With HPV 16 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of Persistent Anogenital Infection With HPV 18 DNA
Time frame: Post Month 7 through Month 24
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.
Incidence of HGAIN Associated With HPV 6
Time frame: Post month 7 through month 24
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.
Incidence of HGAIN Associated With HPV 11
Time frame: Post month 7 through month 24
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.
Incidence of HGAIN Associated With HPV 16
Time frame: Post month 7 through month 24
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.
Incidence of HGAIN Associated With HPV 18
Time frame: Post month 7 through month 24
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.
Incidence of Penile/Scrotal Condyloma in HPV 6 Naive and Prior Exposed Participants
Time frame: Post month 7 through month 24
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Incidence of Penile/Scrotal Condyloma in HPV 11 Naive and Prior Exposed Participants
Time frame: Post month 7 through month 24
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Incidence of Penile/Scrotal Condyloma in HPV 16 Naive and Prior Exposed Participants
Time frame: Post month 7 through month 24
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.
Incidence of Penile/Scrotal Condyloma in HPV 18 Naive and Prior Exposed Participants
Time frame: Post month 7 through month 24
Incident events are defined as having penile/scrotal warts reported clinically in participants penile/scrotal condyloma at baseline.

9 secondary outcomes

Occurrence of Grade ≥ 3 Adverse Events (AEs) That Were Possibly, Probably, or Definitely Related to the Vaccine
Time frame: Through Month 24
Geometric Mean Titers for HPV 6
Time frame: Baseline through month 24
Geometric Mean Titers for HPV 11
Time frame: Baseline through month 24
Geometric Mean Titers for HPV 16
Time frame: Baseline through 24 months
Geometric Mean Titers for HPV 18
Time frame: Baseline through 24 months
Geometric Mean Titers for HPV 6 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Time frame: at 7 and 24 Months
Geometric Mean Titers for HPV 11 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Time frame: at 7 and 24 Months
Geometric Mean Titers for HPV 16 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Time frame: at 7 and 24 Months
Geometric Mean Titers for HPV 18 According to Participant Age, HIV Viral Load, CD4+ T Cell Count, and Nadir CD4 Level
Time frame: at 7 and 24 Months

Results and safety

Results posted to the registry on 27 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vaccination	149	106

Primary outcome: Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA

Time frame: Post Month 7 through Month 24. Number. Unit: Events per 100 person years

Measure	Naive to HPV 6 n = 15	Prior Exposure to HPV 6 n = 34
Value	0.0	11.1

Naive to HPV 6 vs Prior Exposure to HPV 6: p = 0.112, Exact poisson test
Naive to HPV 6: p = 0.447, Exact Poisson calculation

Population analysed: Eligible participants without prevalent HPV 6 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Primary outcome: Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA

Time frame: Post Month 7 through Month 24. Number. Unit: Events per 100 person years

Measure	Naive to HPV 11 n = 35	Prior Exposure to HPV 11 n = 28
Value	0.0	2.2

Naive to HPV 11 vs Prior Exposure to HPV 11: p = 0.224, Exact poisson test
Naive to HPV 11: p = 0.361, Exact Poisson calculation

Population analysed: Eligible participants without prevalent HPV 11 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Primary outcome: Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA

Time frame: Post Month 7 through Month 24. Number. Unit: Events per 100 person years

Measure	Naive to HPV 16 n = 39	Prior Exposure to HPV 16 n = 29
Value	0.0	4.5

Naive to HPV 16 vs Prior Exposure to HPV 16: p = 0.079, Exact poisson test
Naive to HPV 16: p = 0.350, Exact Poisson calculation

Population analysed: Eligible participants without prevalent HPV 16 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

Primary outcome: Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA

Time frame: Post Month 7 through Month 24. Number. Unit: Events per 100 person years

Measure	Naive to HPV 18 n = 47	Prior Exposure to HPV 18 n = 23
Value	0.0	2.8

Naive to HPV 18 vs Prior Exposure to HPV 18: p = 0.162, Exact poisson test
Naive to HPV 18: p = 0.490, Exact Poisson calculation

Population analysed: Eligible participants without prevalent HPV 18 related AIN at baseline who received at least one vaccination and returned after month 7 with evaluable anal/perianal histology and PCR samples.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through 2 years after the first injection of Gardasil.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vaccination	5 of 144 (3.5%)	59 of 144 (41%)	0 of 144

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30658128Kahn 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joel Palefsky, MD principal investigator

University of California, San Francisco

19 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA (time frame: Post Month 7 through Month 24). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01209325, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.