Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

NCT ID: NCT00513526

Last Updated: 2023-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2011-10-31

Brief Summary

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells.

PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.

Detailed Description

OBJECTIVES:

Primary

• To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men.
• To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline.

Secondary

• To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series.
• To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response.
• To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline.
• To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary

• To evaluate prevalent and incident HPV infections in the anal canal.
• To evaluate cytological and histological abnormalities in the anal canal.
• To evaluate prevalent and incident HPV infections in the oral cavity.
• To compare oral and anal compartmental shedding of HPV before and after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24.

After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

Conditions

Infection; Precancerous Condition

Study Design

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

Study Groups

Gardasil

Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.

Group Type: EXPERIMENTAL

Gardasil

Intervention Type: BIOLOGICAL

week 0, 8, 24, 128

Interventions

Gardasil

week 0, 8, 24, 128

Intervention Type: BIOLOGICAL

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

• HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry

• HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test
• Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry
• If receiving antiretroviral therapy:

• Receipt of antiretroviral therapy for at least 6 months prior to entry
• No change in antiretroviral therapy within 30 days prior to entry
• CD4 cell count > 200 cells/mm³ within 90 days prior to study entry
• HIV-1 RNA < 200 copies/mL within 90 days prior to entry
• If 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, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry

• Karnofsky performance status 70-100%
• Absolute neutrophil count > 750 cells/mm³
• Hemoglobin ≥ 9.0 g/dL
• Platelet count ≥ 100,000/mm³
• Creatinine clearance ≥ 60 mL/min
• AST and ALT ≤ 3 times ULN
• Total or conjugated (direct) bilirubin ≤ 2.5 times ULN

• See Disease Characteristics

Exclusion Criteria

• Current or history of anal or perianal carcinoma
• Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results
• Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN

• Current or history of anal or peri-anal condyloma is allowed

PATIENT CHARACTERISTICS:

• Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
• Serious illness requiring systemic treatment and/or hospitalization within the past 45 days
• Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
• Hemophilia

PRIOR CONCURRENT THERAPY:

• Prior splenectomy
• Currently receiving anticoagulation therapy other than acetylsalicylic acid
• Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry

• Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded
• Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C
• Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other HPV vaccine

• Minimum Eligible Age: 18 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

AIDS Malignancy Consortium

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy J. Wilkin, MD, MPH

Role: STUDY_CHAIR

Weill Medical College of Cornell University

Joel Palefsky, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, United States

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Denver Health Medical Center

Denver, Colorado, United States

Boston University Cancer Research Center

Boston, Massachusetts, United States

Laser Surgery Care

New York, New York, United States

New York Weill Cornell Cancer Center at Cornell University

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Benaroya Research Institute at Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

References

Kang M, Umbleja T, Ellsworth G, Aberg J, Wilkin T. Effects of Sex, Existing Antibodies, and HIV-1-Related and Other Baseline Factors on Antibody Responses to Quadrivalent HPV Vaccine in Persons With HIV. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):414-422. doi: 10.1097/QAI.0000000000002891.

Reference Type: DERIVED

PMID: 34907980 (View on PubMed)

Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis. 2010 Oct 15;202(8):1246-53. doi: 10.1086/656320.

Reference Type: DERIVED

PMID: 20812850 (View on PubMed)

Related Links

http://cancer.gov/clinicaltrials/NCT00513526

Clinical trial summary from the National Cancer Institute's PDQ® database

Other Identifiers

CDR0000559149

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA121947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AMC-052

Identifier Type: -

Identifier Source: org_study_id