Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial

Conditions
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Cancer Survivor, Prevention of Human Papillomavirus Infection

Intervention / Treatment
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* Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)
* Other: laboratory biomarker analysis
* Other: survey administration
* Other: medical chart review


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevention (vaccine therapy)<br>Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks. | Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine or nonavalent human papillomavirus vaccine (HPV 6, 11, 16, 18, 31, 33, 45, 52, 58)<br>* Given IM<br>* Other names: Gardasil 9;Other: laboratory biomarker analysis<br>* Correlative studies<br>Other: survey administration<br>* Ancillary studies<br>Other: medical chart review<br>* Ancillary studies<br>* Other names: chart review;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey]) | The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years | At baseline | 
| Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation]) | To demonstrate the non-inferiority of the antibody responses to the HPV vaccine in cancer survivors ages 9 to 26 years when compared to antibody responses of age- and sex-matched historical healthy population. | 1 month following vaccination dose #3 | 
| Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation]) | To demonstrate comparable safety/tolerability of the HPV vaccine in cancer survivors ages 9 to 26 years when compared to age- and sex-matched general population. | Dose 1 through Month 7 |