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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborators: Merck Sharp & Dohme Corp.; The Physicians' Services Incorporated Foundation
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• Females 12-19 years of age

Exclusion Criteria

• Received transplant within the previous 6 months

• Males

• Pregnant

• Previous allergic reaction to any of the vaccine components

• Inadequate documentation of prior immunization