HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
NCT ID: NCT03051516
Last Updated: 2024-02-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
188 participants
INTERVENTIONAL
2017-08-01
2022-12-31
Brief Summary
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Detailed Description
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ARM I: Patients receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline, 2 months, and 6 months.
ARM II: Patients receive placebo IM at baseline, 2 months, and 6 months.
After completion of study treatment, patients are followed up at months 7, 12, 18, 24, 36, and 42.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm I (recombinant human papillomavirus nonavalent vaccine)
Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline, 2 months, and 6 months.
Laboratory Biomarker Analysis
Correlative studies
Questionnaire Administration
Ancillary studies
Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Arm II (placebo)
Patients receive placebo IM at baseline, 2 months, and 6 months.
Laboratory Biomarker Analysis
Correlative studies
Placebo Administration
Given IM
Questionnaire Administration
Ancillary studies
Interventions
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Laboratory Biomarker Analysis
Correlative studies
Placebo Administration
Given IM
Questionnaire Administration
Ancillary studies
Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \>= 2 months since last therapy for HSIL
* No clinical evidence of HSIL on screening examination; if HSIL is suspected, a biopsy will be done to exclude HSIL; patients whose screening visit reveals HSIL on biopsy, may be re-screened \>= 2 months after therapy
* Resident in the catchment area of the clinics and willing to attend up to 8 clinic visits for a 36-month period
* Sexually active women of child-bearing potential must be willing to use effective contraception through month 7 of the study
* If human immunodeficiency virus (HIV) positive, receipt of anti-retroviral therapy continuously for at least 6 months prior to enrollment
* Ability to give informed consent
* Willingness to sign medical records release form and tissue release form
Exclusion Criteria
* Chemotherapy (current, within the last month, or anticipated in the next 7 months)
* Prior history of invasive HPV-related anogenital cancer (cervical, vaginal, vulvar, penile, or anal cancer), or oropharyngeal cancer (base of tongue, tonsil); prior cancer at other sites (including most of oral cavity) or larynx are not exclusions
* Unstable medical condition (e.g., another malignancy requiring treatment, malignant hypertension, poorly controlled diabetes, another cancer except for fully excised non-melanoma skin cancer)
* Prior HPV vaccination
* Known allergy or intolerance to lidocaine
* Currently participating in an interventional research study related to HPV, except the Anal Cancer HSIL Outcomes Research (ANCHOR) study (NCT02135419)
* Any other condition which, in the opinion of the investigator, may compromise the subject's ability to follow study procedures and safely complete the study
27 Years
69 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Margaret M. Madeleine, PhD
Professor
Principal Investigators
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Anna Wald
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Stankiewicz Karita HC, Hauge K, Magaret A, Mao C, Schouten J, Grieco V, Xi LF, Galloway DA, Madeleine MM, Wald A. Effect of Human Papillomavirus Vaccine to Interrupt Recurrence of Vulvar and Anal Neoplasia (VIVA): A Trial Protocol. JAMA Netw Open. 2019 Apr 5;2(4):e190819. doi: 10.1001/jamanetworkopen.2019.0819.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2017-00151
Identifier Type: REGISTRY
Identifier Source: secondary_id
9790
Identifier Type: OTHER
Identifier Source: secondary_id
RG1001522
Identifier Type: OTHER
Identifier Source: secondary_id
9790
Identifier Type: -
Identifier Source: org_study_id
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