vaccine therapy in preventing human papillomavirus infection in younger cancer survivors

Conditions: Cancer Survivor; Prevention of Human Papillomavirus Infection

Summary: 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 and nonavalent hpv vaccine in young 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.

Eligibility criteria:
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)