Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

Phase 2

Completed

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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)

Primary Outcome Measures

Name	Time	Method
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])	1 month following vaccination dose #3	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.
Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])	At baseline	The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])	Dose 1 through Month 7	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.

Secondary Outcome Measures

Name	Time	Method

Locations (5): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
City of Hope Medical Center
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Duarte, California, United States
Emory University School Of Medicine
🇺🇸
Atlanta, Georgia, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
Saint Jude Children's Research Hospital
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Memphis, Tennessee, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States