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 HPV vaccine in young cancer survivors.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01492582.
PRIMARY OBJECTIVES:
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 quadrivalent (q) HPV 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 qHPV 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 (types 6, 11, 16, and 18) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
Lead OrganizationUniversity of Alabama at Birmingham Cancer Center
Principal InvestigatorWendy Landier
