Know Cancer

or
forgot password

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


Phase 2
9 Years
26 Years
Open (Enrolling)
Both
Cancer Survivor, Human Papilloma Virus Infection

Thank you

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 MichiganAnn Arbor, Michigan  48109-0624
Emory University School of MedicineAtlanta, Georgia  30322
City of Hope Medical CenterDuarte, California  91010
Saint Jude Childrens Research HospitalMemphis, Tennessee  38105