Vaccine Therapy in Preventing Human Papillomavirus Infection in Younger Cancer Survivors

The University of Alabama at Birmingham

Status and phase: Completed; Phase 2

Conditions: Cancer Survivor; Prevention of Human Papillomavirus Infection

Treatments: Other: laboratory biomarker analysis; Other: survey administration; Other: medical chart review; 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)

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01492582

UAB-F141204009/UAB-X141204010

1R01CA166559 (U.S. NIH Grant/Contract)

NCI-2011-03654 (Registry Identifier)

Merck-IISP#40083 (Other Identifier)

COH-11034 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,499 patients

Sex: All

Ages: 9 to 26 years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,499 participants in 1 patient group

Prevention (vaccine therapy)

Experimental group

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.

Treatment:

Other: laboratory biomarker analysis

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: medical chart review

Other: survey administration