Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

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 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.

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 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.

Inclusion Criteria:

- AIM 1 (SURVEY) (AIM 1 is closed to enrollment)

- Cancer survivor

- Between 12 and 60 months after completion of cancer therapy (chemotherapy, radiation,
hematopoietic cell transplant [HCT])

- Scheduled for a return clinic visit at one of the participating institutions

- English or Spanish-speaking

- Willing to provide informed consent/assent for study participation

- AIM 2 (VACCINE EVALUATION)

- Meets all inclusion criteria outlined in Aim 1

- Survey response indicated no prior history of HPV vaccination OR patient has no prior
history of HPV vaccination by self - or parent/caregiver-report

- English or Spanish-speaking

- Medical clearance from treating clinician for study participation

- Agrees to return to participating institution for 3 HPV vaccine injections

- Willing to provide informed consent/assent for study participation

Exclusion Criteria:

- AIM 2 (VACCINE EVALUATION)

- Allergy to any component of the HPV vaccine including yeast and aluminum

- Thrombocytopenia (platelet count < 50K) or coagulation disorder that would
contraindicate intramuscular injection

- Transfusion of blood products or intravenous immune globulin within 3 months of study
entry

- Female, and a) currently pregnant or lactating, or b) of childbearing potential and
unwilling to avoid pregnancy during the vaccine phase of study (beginning at Day 1 and
continuing until at least 4 weeks after all 3 vaccine doses have been administered)