NCT01492582

Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,499 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 9 Years – 26 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer Survivor
• Prevention of Human Papillomavirus Infection

Interventions

Type	Name	Description
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)	Given IM
OTHER	laboratory biomarker analysis	Correlative studies
OTHER	survey administration	Ancillary studies
OTHER	medical chart review	Ancillary studies

Timeline

• Start date: 2012-07-01
• Primary completion: 2019-02-08
• Completion: 2020-07-20
• First posted: 2011-12-15
• Last updated: 2021-10-27
• Results posted: 2020-04-30

Locations

5 sites across 1 country: United States