Clinical trial NCT01492582: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer Survivor
Prevention of Human Papillomavirus Infection
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Merck Sharp & Dohme LLC
First posted: 2011-12-15
Enrollment: 1499
Sex: ALL
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: Prevalence of HPV Vaccine Initiation in Cancer Survivors (Aim 1 [Survey])
timeFrame: At baseline
measure: Immunogenicity of the HPV Vaccine in Cancer Survivors (Anti-HPV 16 and 18 Geometric Mean Titers) (Aim 2 [Vaccine Evaluation])
timeFrame: 1 month following vaccination dose #3
measure: Safety/Tolerability of the HPV Vaccine in Cancer Survivors (Aim 2 [Vaccine Evaluation])
timeFrame: Dose 1 through Month 7
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Atlanta
country: United States
facility: Emory University School Of Medicine
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Memphis
country: United States
facility: Saint Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: University of Alabama at Birmingham
name: Wendy Landier, PhD, CRNP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.