Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

University of Alabama at Birmingham1,499 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

1,499

Conditions

Cancer Survivor Prevention of Human Papillomavirus Infection

Interventions

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)BIOLOGICAL

Given IM

laboratory biomarker analysisOTHER

Correlative studies

survey administrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 9 YearsMax age: 26 Years

Medical Language ↔ Plain English

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)

Locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope Medical Center

Duarte, California, United States

Emory University School Of Medicine

Atlanta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: Dose 1 through Month 7

Data from ClinicalTrials.gov

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