Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
NCT ID: NCT01492582
Last Updated: 2021-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1499 participants
INTERVENTIONAL
2012-07-31
2020-07-20
Brief Summary
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Detailed Description
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I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
II. Using a single-arm, phase II, open-label, prospective longitudinal trial design, to evaluate the 3-dose HPV quadrivalent (HPV4) and nonavalent (HPV9) vaccine series and measure the following endpoints: a) Determine immunogenicity following the third and final vaccine dose; b) Identify clinical/host factors influencing immunogenicity; c) Determine the safety/tolerability of the HPV vaccine in cancer survivors.
III. Evaluate the persistence of antibody response at 2 years post vaccine initiation and identify clinical/host factors influencing response persistence.
OUTLINE:
AIM 1 (SURVEY): Patients (ages 18-26 years) or their parents (for patients ages 9-17 years) complete a survey regarding the patient's HPV vaccination status, knowledge of HPV-related disease, and factors important in making decisions regarding vaccination.
AIM 2 (VACCINE EVALUATION): Patients not previously immunized against HPV receive quadrivalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, for patients enrolled on or before 3/1/16) or the nonavalent human papillomavirus recombinant vaccine (HPV-6, -11, -16, -18, -31, -33, -45, -52, -58, for patients enrolled after 3/1/16) intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Prevention (vaccine therapy)
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)
Given IM
laboratory biomarker analysis
Correlative studies
survey administration
Ancillary studies
medical chart review
Ancillary studies
Interventions
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quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)
Given IM
laboratory biomarker analysis
Correlative studies
survey administration
Ancillary studies
medical chart review
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cancer survivor
* Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation, hematopoietic cell transplant \[HCT\])
* Scheduled for a return clinic visit at one of the participating institutions
* English or Spanish-speaking
* Willing to provide informed consent/assent for study participation
* AIM 2 (VACCINE EVALUATION)
* Survey response indicated no prior history of HPV vaccination OR patient has no prior history of HPV vaccination by self - or parent/caregiver-report
* English or Spanish-speaking
* Medical clearance from treating clinician for study participation
* Agrees to return to participating institution for 3 HPV vaccine injections
* Willing to provide informed consent/assent for study participation
Exclusion Criteria
* Allergy to any component of the HPV vaccine including yeast and aluminum
* Thrombocytopenia (platelet count \< 50K) or coagulation disorder that would contraindicate intramuscular injection
* Transfusion of blood products or intravenous immune globulin within 3 months of study entry
* Female, and a) currently pregnant or lactating, or b) of childbearing potential and unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and continuing until at least 4 weeks after all 3 vaccine doses have been administered)
9 Years
26 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Merck Sharp & Dohme LLC
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
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Wendy Landier
Principal Investigator
Principal Investigators
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Wendy Landier, PhD, CRNP
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope Medical Center
Duarte, California, United States
Emory University School Of Medicine
Atlanta, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Landier W, Bhatia S, Wong FL, York JM, Flynn JS, Henneberg HM, Singh P, Adams K, Wasilewski-Masker K, Cherven B, Jasty-Rao R, Leonard M, Connelly JA, Armenian SH, Robison LL, Giuliano AR, Hudson MM, Klosky JL. Immunogenicity and safety of the human papillomavirus vaccine in young survivors of cancer in the USA: a single-arm, open-label, phase 2, non-inferiority trial. Lancet Child Adolesc Health. 2022 Jan;6(1):38-48. doi: 10.1016/S2352-4642(21)00278-9. Epub 2021 Nov 10.
York JM, Klosky JL, Chen Y, Connelly JA, Wasilewski-Masker K, Giuliano AR, Robison LL, Wong FL, Hudson MM, Bhatia S, Landier W. Patient-Level Factors Associated With Lack of Health Care Provider Recommendation for the Human Papillomavirus Vaccine Among Young Cancer Survivors. J Clin Oncol. 2020 Sep 1;38(25):2892-2901. doi: 10.1200/JCO.19.02026. Epub 2020 Jun 18.
Cherven B, Castellino SM, Chen Y, Wong FL, York JM, Wasilewski-Masker K, Hudson MM, Bhatia S, Klosky JL, Landier W. Intent and subsequent initiation of human papillomavirus vaccine among young cancer survivors. Cancer. 2019 Nov 1;125(21):3810-3817. doi: 10.1002/cncr.32379. Epub 2019 Jul 10.
Klosky JL, Hudson MM, Chen Y, Connelly JA, Wasilewski-Masker K, Sun CL, Francisco L, Gustafson L, Russell KM, Sabbatini G, Flynn JS, York JM, Giuliano AR, Robison LL, Wong FL, Bhatia S, Landier W. Human Papillomavirus Vaccination Rates in Young Cancer Survivors. J Clin Oncol. 2017 Nov 1;35(31):3582-3590. doi: 10.1200/JCO.2017.74.1843. Epub 2017 Aug 24.
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-2011-03654
Identifier Type: REGISTRY
Identifier Source: secondary_id
Merck-IISP#40083
Identifier Type: OTHER
Identifier Source: secondary_id
COH-11034
Identifier Type: OTHER
Identifier Source: secondary_id
UAB-F141204009/UAB-X141204010
Identifier Type: -
Identifier Source: org_study_id