Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

Phase 2

Completed

• Conditions: Prevention of Human Papillomavirus Infection; Cancer Survivor
• Interventions: 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

• Registration Number: NCT01492582
• Lead Sponsor: University of Alabama at Birmingham

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Study Start: 2012-07
• Primary Completion: 2019-02-08
• Results First Submitted: 2020-02-06
• Results First Submitted QC: 2020-04-17
• Results First Posted: 2020-04-30
• Study Completion: 2020-07-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1499

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (vaccine therapy)	survey administration	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.
Prevention (vaccine therapy)	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)	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.
Prevention (vaccine therapy)	laboratory biomarker analysis	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.
Prevention (vaccine therapy)	medical chart review	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.

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.

Trial Locations

Locations (5)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Emory University School Of Medicine; 🇺🇸 Atlanta, Georgia, United States

Saint Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States

City of Hope Medical Center; 🇺🇸 Duarte, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States