Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

• Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey]) [ Time Frame: At baseline ] [ Designated as safety issue: No ]
  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 quadrivalent HPV vaccine in cancer survivors (anti-HPV 6, 11, 16, and 18 geometric mean titers) (Aim 2 [vaccine evaluation]) [ Time Frame: 1 month following vaccination dose #3 ] [ Designated as safety issue: No ]
  To demonstrate the non-inferiority of the antibody responses to quadrivalent 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 quadrivalent HPV vaccine in cancer survivors (Aim 2 [vaccine evaluation]) [ Time Frame: Through 14 days following last vaccine dose ] [ Designated as safety issue: Yes ]
  To demonstrate comparable safety/tolerability of the quadrivalent HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population
  
  

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.