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Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

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ClinicalTrials.gov Identifier: NCT01492582
Recruitment Status : Recruiting
First Posted : December 15, 2011
Last Update Posted : October 16, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Wendy Landier, University of Alabama at Birmingham

December 12, 2011
December 15, 2011
October 16, 2017
July 2012
January 2019   (Final data collection date for primary outcome measure)
  • Prevalence of HPV vaccine initiation in cancer survivors (Aim 1 [survey]) [ Time Frame: At baseline ]
    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.
  • Immunogenicity of the HPV vaccine in cancer survivors (anti-HPV 6 and 11 geometric mean titers) (Aim 2 [vaccine evaluation]) [ Time Frame: 1 month following vaccination dose #3 ]
    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]) [ Time Frame: Through 7-14 days following last vaccine dose ]
    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
  • HPV vaccine non-initiation (Aim 1 [survey]) [ Time Frame: At baseline ]
    The prevalence of qHPV vaccine initiation and its 2-sided 95% confidence intervals (CI) will be calculated. A one-sided t-test will be conducted using Type I error=0.05. Significant predictors of vaccine initiation will be identified using logistic regression.
  • HPV antibody titers (anti-HPV 6, 11, 16, and 18) (Aim 2 [vaccine evaluation]) [ Time Frame: 24 months following vaccination dose #1 ]
    The primary analytic approach will be per-protocol analysis; intention to treat analysis will be conducted. Seropositivity rates (binary variable) will be assessed. A multiplicity-adjusted 95% 2-sided confidence intervals for the ratio of mean GMT for HPV-16 and -18 will be computed. One-sided tests of non-inferiority for each HPV type will be conducted at the 0.025 (multiplicity adjusted) level according to the methods of Miettinen and Nurminen.
  • Vaccine report card (participant/parent diary of adverse events) (Aim 2 [vaccine evaluation]) [ Time Frame: Through 14 days following last vaccine dose ]
    Logistic regression will be used to identify significant predictors of lowered immunogenicity.
  • Telephone follow-up form (Aim 2 [vaccine evaluation]) [ Time Frame: Through 72 hours following last vaccine dose ]
  • Adverse event reporting forms (Safety/tolerability) (Aim 2 [vaccine evaluation]) [ Time Frame: Through 5 days following last vaccine dose ]
    Chi-square and exact tests will be used for comparison depending on the rarity of events.
Complete list of historical versions of study NCT01492582 on ClinicalTrials.gov Archive Site
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Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors
Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Cancer Survivor
  • Prevention of Human Papillomavirus Infection
  • 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)
    Given IM
    Other Names:
    • Gardasil
    • Gardasil 9
  • Other: laboratory biomarker analysis
    Correlative studies
  • Other: survey administration
    Ancillary studies
  • Other: medical chart review
    Ancillary studies
    Other Name: chart review
Experimental: Prevention (vaccine therapy)
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.
Interventions:
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1268
1090
July 2020
January 2019   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
9 Years to 26 Years   (Child, Adult)
No
United States
 
 
NCT01492582
UAB-F141204009/UAB-X141204010
NCI-2011-03654 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1R01CA166559 ( U.S. NIH Grant/Contract )
Merck-IISP#40083 ( Other Identifier: Merck & Co. )
COH-11034 ( Other Identifier: City of Hope IRB )
Yes
Not Provided
Not Provided
Wendy Landier, University of Alabama at Birmingham
University of Alabama at Birmingham
  • National Cancer Institute (NCI)
  • Merck Sharp & Dohme Corp.
Principal Investigator: Wendy Landier, PhD, CRNP University of Alabama at Birmingham
University of Alabama at Birmingham
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP