Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

NCT01492582 | Completed Phase 2 Results DMC

• 5 other identifiers: UAB-F141204009/UAB-X141204010NCI-2011-036541R01CA166559Merck-IISP#40083COH-11034
• Study Type: interventional
• Target: 1,499
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer Survivor; Prevention of Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (3)

• 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

  At baseline

• 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.

  1 month following vaccination dose #3

• 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.

  Dose 1 through Month 7

Study Arms (1)

Prevention (vaccine therapy)

EXPERIMENTAL

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.

Biological: 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: laboratory biomarker analysis; Other: survey administration; Other: medical chart review

Interventions

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) BIOLOGICAL

Given IM

Also known as: Gardasil, Gardasil 9

Prevention (vaccine therapy)

laboratory biomarker analysis OTHER

Correlative studies

Prevention (vaccine therapy)

survey administration OTHER

Ancillary studies

Prevention (vaccine therapy)

medical chart review OTHER

Ancillary studies

Also known as: chart review

Prevention (vaccine therapy)

Eligibility Criteria

• Age: 9 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Cancer Institute (NCI): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (5)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Emory University School Of Medicine

Atlanta, Georgia, 30308, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Saint Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (4)

• 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.

  PMID: 34767765 DERIVED

• 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.

  PMID: 32552278 DERIVED

• 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.

  PMID: 31291010 DERIVED

• 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.

  PMID: 28837404 DERIVED

MeSH Terms

Interventions

Vaccines, Synthetic; Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; Human Papillomavirus Recombinant Vaccine nonavalent

Intervention Hierarchy (Ancestors)

Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; Antigens; Biological Factors; Vaccines, Combined; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Dr. Wendy Landier, Deputy Director, Institute for Cancer Outcomes and Survivorship
• Organization: University of Alabama at Birmingham

wlandier@peds.uab.edu

(205) 638-2120

Study Officials

• Wendy Landier, PhD, CRNP

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2011
• First Posted: December 15, 2011
• Study Start: July 1, 2012
• Primary Completion: February 8, 2019
• Study Completion: July 20, 2020
• Last Updated: October 27, 2021
• Results First Posted: April 30, 2020

Record last verified: 2021-10

Locations

US (5)