Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT01492582|
Recruitment Status : Recruiting
First Posted : December 15, 2011
Last Update Posted : October 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer Survivor Prevention of Human Papillomavirus Infection||Biological: 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) Other: laboratory biomarker analysis Other: survey administration Other: medical chart review||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1268 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: 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.
Biological: 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)
Other Names:Other: laboratory biomarker analysis
Correlative studiesOther: survey administration
Ancillary studiesOther: medical chart review
Other Name: chart review
- Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey]) [ Time Frame: At baseline ]To estimate the prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years and to examine the sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
- Immunogenicity of the HPV vaccine in cancer survivors (anti-HPV 6 and 11 geometric mean titers) (Aim 2 [vaccine evaluation]) [ Time Frame: 1 month following vaccination dose #3 ]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.
- Safety/tolerability of the HPV vaccine in cancer survivors (Aim 2 [vaccine evaluation]) [ Time Frame: Through 7-14 days following last vaccine dose ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492582
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Wendy Landier, PhD, CRNP 205-638-2120 firstname.lastname@example.org|
|Principal Investigator: Wendy Landier, PhD, CRNP|
|United States, California|
|City of Hope Medical Center||Active, not recruiting|
|Duarte, California, United States, 91010|
|United States, Georgia|
|Emory University School Of Medicine||Recruiting|
|Atlanta, Georgia, United States, 30308|
|Contact: Karen Wasilewski-Masker, MD 404-536-5747 email@example.com|
|Principal Investigator: Karen Wasilewski-Masker, MD|
|United States, Michigan|
|University of Michigan||Active, not recruiting|
|Ann Arbor, Michigan, United States, 48109|
|United States, Tennessee|
|Saint Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: James Klosky, PhD 901-595-5057 firstname.lastname@example.org|
|Principal Investigator: James Klosky, PhD|
|Principal Investigator:||Wendy Landier, PhD, CRNP||University of Alabama at Birmingham|