Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

Cancer Survivor Clinical Trial

Official title:

Quadrivalent Human Papillomavirus (qHPV) Vaccine in Cancer Survivors: Cross Sectional Survey and Phase II Open-Label Vaccine Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492582
• Other study ID #: UAB-F141204009/UAB-X141204010
• Secondary ID: NCI-2011-036541R
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: July 20, 2020

Study information

• Verified date: October 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1499
• Est. completion date: July 20, 2020
• Est. primary completion date: February 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 26 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cancer Survivor
• Infections
• Papillomavirus Infections
• Prevention of Human Papillomavirus Infection

Intervention

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:
• laboratory biomarker analysis
Correlative studies
• survey administration
Ancillary studies
• medical chart review
Ancillary studies

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University School Of Medicine	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	City of Hope Medical Center	Duarte	California
United States	Saint Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Merck Sharp & Dohme Corp., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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