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

NCT02624349 | Completed Phase 4

• 1 other identifier: 1000037024
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Immunogenicity (Serum anti-HPV 6, 11, 16, and 18 antibody measured using a competitive Luminex immunoassay)

  Serum anti-HPV 6, 11, 16, and 18 antibody will be measured using a competitive Luminex immunoassay (cLIA; reported in milli-Merck Units/ml). Seropositivity will be defined as an anti-HPV titre ≥20, 16, 20, and 24/ml, for HPV types 6, 11, 16, and 18, respectively

  4-6 weeks

Secondary Outcomes (1)

• Immunogenicity (Serum anti-HPV 6, 11, 16, and 18 antibody measured using a competitive Luminex immunoassay)

  1 year

Other Outcomes (1)

• Adverse event following immunization (AEFI)

  48 hours and 1 week

Study Arms (2)

Transplant

ACTIVE COMPARATOR

Intervention: Quadravalent human papillomavirus vaccine 0.5ml intramuscular injection at 0, 2, and 6 months and/or post administration antibody titers as described in methods

Drug: Quadravalent human papillomavirus vaccine

Control

ACTIVE COMPARATOR

Intervention: Quadravalent human papillomavirus vaccine 0.5ml intramuscular injection at 0, 2, and 6 months and/or post administration antibody titers as described in methods

Drug: Quadravalent human papillomavirus vaccine

Interventions

Quadravalent human papillomavirus vaccine DRUG

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

Also known as: Gardasil

Control; Transplant

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- Females 12-19 years of age

You may not qualify if:

• Received transplant within the previous 6 months
• Males
• Pregnant
• Previous allergic reaction to any of the vaccine components
• Inadequate documentation of prior immunization

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• The Physicians' Services Incorporated Foundation: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Study Officials

• Upton Allen, MD MSc

  The Hospital for Sick Chidren

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, division of infectious diseases, department of pediatrics

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: December 8, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)