Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
I. Using a cross-sectional survey approach, estimate the prevalence of HPV vaccine
non-initiation: a) Examine sociodemographic, behavioral, and medical determinants of HPV
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.
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey])
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.
City of Hope Medical Center
United States: Federal Government
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|Emory University School of Medicine||Atlanta, Georgia 30322|
|City of Hope Medical Center||Duarte, California 91010|
|Saint Jude Childrens Research Hospital||Memphis, Tennessee 38105|