Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 1,499
- Locations
- 10
- Primary Endpoint
- Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 9 Years to 26 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
Time Frame: 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])
Time Frame: 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])
Time Frame: 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 Outcomes
No secondary outcomes reported
Investigators
Wendy Landier
Principal Investigator
University of Alabama at Birmingham