Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
9 Years
26 Years
Both
Cancer Survivor, Human Papilloma Virus Infection
Trial Information
Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
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 quadrivalent (q) HPV 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 qHPV 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 (types 6, 11, 16, and 18) recombinant vaccine
intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
Inclusion Criteria:
- AIM 1 (SURVEY)
- 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
- 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)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey])
Outcome Description:
To estimate the prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years and to examine the sociodemographic, behavioral, and medical determinants of HPV vaccine non-initiation.
Outcome Time Frame:
At baseline
Safety Issue:
No
Principal Investigator
Wendy Landier
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Federal Government
Study ID:
11034
NCT ID:
NCT01492582
Start Date:
July 2012
Completion Date:
Related Keywords:
- Cancer Survivor
- Human Papilloma Virus Infection
- Papilloma
- Virus Diseases
- Warts
- Papillomavirus Infections
Name | Location |
|---|---|
| University of Michigan | Ann Arbor, Michigan 48109-0624 |
| Emory University School of Medicine | Atlanta, Georgia 30322 |
| City of Hope Medical Center | Duarte, California 91010 |
| Saint Jude Childrens Research Hospital | Memphis, Tennessee 38105 |
