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Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

Primary Purpose

Cancer Survivor, Prevention of Human Papillomavirus Infection

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
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)
laboratory biomarker analysis
survey administration
medical chart review
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer Survivor

Eligibility Criteria

9 Years - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope Medical Center
  • Emory University School Of Medicine
  • University of Michigan
  • Saint Jude Children's Research Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (vaccine therapy)

Arm Description

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.

Outcomes

Primary Outcome Measures

Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
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.
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
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 Outcome Measures

Full Information

First Posted
December 12, 2011
Last Updated
October 7, 2021
Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI), Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01492582
Brief Title
Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Official Title
Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
February 8, 2019 (Actual)
Study Completion Date
July 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Cancer Institute (NCI), Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivor, Prevention of Human Papillomavirus Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention (vaccine therapy)
Arm Type
Experimental
Arm Description
Patients receive quadrivalent human papillomavirus (types 6, 11, 16, and 18, for patients enrolled on or before 3/1/16) or nonavalent human papillomavirus (types 6, 11, 16, 18, 31, 33, 45, 52, and 58, for patients enrolled after 3/1/16) recombinant vaccine intramuscularly on day 1, at 8-12 weeks, and at 24-32 weeks.
Intervention Type
Biological
Intervention Name(s)
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)
Other Intervention Name(s)
Gardasil, Gardasil 9
Intervention Description
Given IM
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Intervention Type
Other
Intervention Name(s)
survey administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
medical chart review
Other Intervention Name(s)
chart review
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
Description
The prevalence of HPV vaccine initiation in cancer survivors ages 9 to 26 years
Time Frame
At baseline
Title
Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
Description
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.
Time Frame
1 month following vaccination dose #3
Title
Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
Description
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.
Time Frame
Dose 1 through Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Landier, PhD, CRNP
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Emory University School Of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34767765
Citation
Landier W, Bhatia S, Wong FL, York JM, Flynn JS, Henneberg HM, Singh P, Adams K, Wasilewski-Masker K, Cherven B, Jasty-Rao R, Leonard M, Connelly JA, Armenian SH, Robison LL, Giuliano AR, Hudson MM, Klosky JL. Immunogenicity and safety of the human papillomavirus vaccine in young survivors of cancer in the USA: a single-arm, open-label, phase 2, non-inferiority trial. Lancet Child Adolesc Health. 2022 Jan;6(1):38-48. doi: 10.1016/S2352-4642(21)00278-9. Epub 2021 Nov 10.
Results Reference
derived
PubMed Identifier
32552278
Citation
York JM, Klosky JL, Chen Y, Connelly JA, Wasilewski-Masker K, Giuliano AR, Robison LL, Wong FL, Hudson MM, Bhatia S, Landier W. Patient-Level Factors Associated With Lack of Health Care Provider Recommendation for the Human Papillomavirus Vaccine Among Young Cancer Survivors. J Clin Oncol. 2020 Sep 1;38(25):2892-2901. doi: 10.1200/JCO.19.02026. Epub 2020 Jun 18.
Results Reference
derived
PubMed Identifier
31291010
Citation
Cherven B, Castellino SM, Chen Y, Wong FL, York JM, Wasilewski-Masker K, Hudson MM, Bhatia S, Klosky JL, Landier W. Intent and subsequent initiation of human papillomavirus vaccine among young cancer survivors. Cancer. 2019 Nov 1;125(21):3810-3817. doi: 10.1002/cncr.32379. Epub 2019 Jul 10.
Results Reference
derived
PubMed Identifier
28837404
Citation
Klosky JL, Hudson MM, Chen Y, Connelly JA, Wasilewski-Masker K, Sun CL, Francisco L, Gustafson L, Russell KM, Sabbatini G, Flynn JS, York JM, Giuliano AR, Robison LL, Wong FL, Bhatia S, Landier W. Human Papillomavirus Vaccination Rates in Young Cancer Survivors. J Clin Oncol. 2017 Nov 1;35(31):3582-3590. doi: 10.1200/JCO.2017.74.1843. Epub 2017 Aug 24.
Results Reference
derived

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Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

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