CSqHPV: 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 A Consortium for Pediatric Interventional Research

Categories:

Psychology

Phase I/II

Diseases Treated:

Human papillomavirus

Eligibility Overview:

This is a non-therapeutic clinical trial that is only open to St. Jude patients.

Questionnaire phase

  • Cancer survivor (9 to 26 years of age at study participation)
  • English or Spanish-speaking

Vaccine Phase

  • Survey response indicated no prior history of HPV vaccination
  • Agrees to return to participating institution for 3 HPV vaccine injections
  • Allergy to any component of the HPV vaccine including yeast and aluminum will not be eligible for the study

Description

Participants for this study are cancer survivors between 9 and 26 years of age who completed cancer therapy between 12 and 60 months previously. The first phase of this study will involve completion of a questionnaire which asks participants about their knowledge, attitudes, and beliefs regarding human papillomavirus (HPV), in addition to history of HPV vaccination. 

Cancer survivors between 9 and 17 years of age will have the questionnaire completed by their parent(s) / guardian(s), whereas young adult participants will personally complete the study questionnaire. Participants who have not yet initiated the HPV vaccine will be asked to participate in the second phase of the study, which will involve the administration of the HPV vaccine.

Genital human papillomavirus (also called HPV) is the most common sexually transmitted infection (STI). There are more than 40 HPV types that can infect the genital areas of males and females. These HPV types can also infect the mouth and throat. 

Most people who become infected with HPV do not even know they have it. Studies in healthy people have found that the HPV vaccine can prevent most diseases caused by the four HPV subtypes that the vaccine protects against. 

Cancer treatments, such as chemotherapy, radiation, and/or hematopoietic cell transplantation can place cancer survivors at higher risk for experiencing an HPV-related complication than people in the general population. However, no studies to date have reported if the immune systems of cancer survivors are able to mount protective antibody responses to the HPV vaccine that are similar to those known to occur in the general population.

Objectives

  • Identify the proportion of young cancer survivors who have initiated the Human papillomavirus (HPV) vaccine
  • Understand the factors associated with decisions to obtain/reject this vaccine
  • Study if the vaccine protects cancer survivors against HPV, just like it does in people who have never had cancer
  • Potentially find better ways to protect cancer survivors from HPV-related diseases

Eligibility

For Questionnaire Phase:

  • Cancer survivor (9 to 26 years of age at study participation)
  • English or Spanish-speaking
  • Willing to provide consent / assent for study participation

For Vaccine Phase:

  • Survey response indicated no prior history of HPV vaccination
  • 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
  • Allergy to any component of the HPV vaccine including yeast and aluminum will not be eligible for the study and
  • 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).

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Principal Investigator

James Klosky, PhD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.