Status:
COMPLETED
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Cancer Institute (NCI)
Merck Sharp & Dohme LLC
Conditions:
Cancer Survivor
Prevention of Human Papillomavirus Infection
Eligibility:
All Genders
9-26 years
Phase:
PHASE2
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 youn...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2020
Estimated Enrollment :
1499 Patients enrolled
Trial Details
Trial ID
NCT01492582
Start Date
July 1 2012
End Date
July 20 2020
Last Update
October 27 2021
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
City of Hope Medical Center
Duarte, California, United States, 91010
3
Emory University School Of Medicine
Atlanta, Georgia, United States, 30308
4
University of Michigan
Ann Arbor, Michigan, United States, 48109