Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
NIH
OTHER · Merck & Co.
OTHER · City of Hope IRB
interventional
1,499
1 country
5
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 8, 2019
Actual (reported)Study Completion
July 20, 2020
Actual (reported)This trial will comprehensively evaluate the human papillomavirus (HPV) vaccine in cancer survivors between 9 and 26 years of age by (1) determining the prevalence of HPV vaccine initiation among young cancer survivors, and (2) determining the immune response to and safety/tolerability of the quadrivalent and nonavalent HPV vaccine in young cancer survivors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 20, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 12, 2011
Actual (reported)December 15, 2011
Actual (reported)July 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 8, 2019
Actual (reported)April 30, 2020
Actual (reported)July 20, 2020
Actual (reported)Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
At baseline
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population.
1 month following vaccination dose #3
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population.
Dose 1 through Month 7
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.
Given IM
Correlative studies
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Emory University School Of Medicine
Atlanta, Georgia, 30308, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
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.
Wendy Landier, PhD, CRNP
University of Alabama at Birmingham
1,499 participants (actual enrollment reported by the registry).
First Submitted
December 12, 2011
First Posted
December 15, 2011
Study Start
July 2012
Date type not reportedThis date has not been verified as actual or estimated.
Ancillary studies
Ancillary studies
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
February 8, 2019
Actual (reported)Study Completion
July 20, 2020
Actual (reported)Last Updated
October 27, 2021
Results First Posted
April 30, 2020
Record last verified: 2021-10
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Source: ClinicalTrials.gov.
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