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Immunogenicity and Safety of Human Papilloma Virus Vaccine in Solid Organ Transplant Recipients

NCT02624349 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-02-15

No results posted yet for this study

Summary

The human papilloma virus (HPV) is known to be an important cause of cervical and anal cancers. Studies on patients who have received a solid organ transplant (such as a liver or kidney transplant) have suggested the risk of HPV-related cancers may be higher in this population. The HPV vaccine, Gardasil®, has been approved for use in males and females by Health Canada. In studies on healthy subjects this vaccine is nearly 100% effective at preventing infections from HPV serotypes that are in the vaccine. These serotypes, representing different viral strains, are known to cause 70% of cervical cancers and 90% of genital warts. The vaccine was also shown to be very safe and well tolerated in healthy subjects. Transplant patients are at higher risk of HPV related complications and cancers. As a result transplant experts have recommended this vaccine for use in their patients; however there have been no studies looking at the response to vaccination or safety of this vaccine in solid organ transplant recipients. Our objective is to study the immune response and side effects of Gardasil® in children who have received kidney or liver transplants. We will study this by comparing immune responses to the vaccine in healthy adolescent females compared to female liver and kidney transplant recipients. We will be recruiting females ages 12-19, as the province of Ontario funds the vaccine for this group. We will evaluate the transplant subjects for side effects after they receive the vaccine. Our hypothesis is that transplant recipients will have lower immunogenicity than healthy controls.

Conditions

  • Late Complication From Kidney Transplant
  • Complication of Transplanted Liver
  • Human Papillomavirus-Related Carcinoma

Interventions

DRUG

Quadravalent human papillomavirus vaccine

Vaccine will be administered to all transplant recipients. Controls will be recruited based on previous documented receipt of vaccine

Sponsors & Collaborators

  • The Physicians' Services Incorporated Foundation

    collaborator OTHER

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Upton Allen, MD MSc · The Hospital for Sick Chidren

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624349 on ClinicalTrials.gov