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

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ClinicalTrials.gov Identifier: NCT02624349
Recruitment Status : Unknown
Verified December 2016 by Upton Allen, The Hospital for Sick Children.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2015
Last Update Posted : December 7, 2016
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Upton Allen, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Late Complication From Kidney Transplant Complication of Transplanted Liver Human Papillomavirus-Related Carcinoma Drug: Quadravalent human papillomavirus vaccine Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Human Papilloma Virus Vaccine in Solid Organ Transplant Recipients
Study Start Date : October 2013
Actual Primary Completion Date : April 2016
Estimated Study Completion Date : May 2017

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Arm Intervention/treatment
Active Comparator: Transplant
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
Vaccine will be administered to all transplant recipients. Controls will be recruited based on previous documented receipt of vaccine
Other Name: Gardasil

Active Comparator: Control
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
Vaccine will be administered to all transplant recipients. Controls will be recruited based on previous documented receipt of vaccine
Other Name: Gardasil




Primary Outcome Measures :
  1. Immunogenicity (Serum anti-HPV 6, 11, 16, and 18 antibody measured using a competitive Luminex immunoassay) [ Time Frame: 4-6 weeks ]
    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


Secondary Outcome Measures :
  1. Immunogenicity (Serum anti-HPV 6, 11, 16, and 18 antibody measured using a competitive Luminex immunoassay) [ Time Frame: 1 year ]
    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


Other Outcome Measures:
  1. Adverse event following immunization (AEFI) [ Time Frame: 48 hours and 1 week ]
    phone calls will be made at 48hrs and 7 days to evaluate for any adverse events. The Public Health Ontario AEFI form will be used to identify local reactions, fevers, neurological complaints, and other temporally associated events. Any identified reactions are then quantified by severity and duration as indicated on the form. Adverse events will be qualitatively described.



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Ages Eligible for Study:   12 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624349


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
The Hospital for Sick Children
The Physicians' Services Incorporated Foundation
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Upton Allen, MD MSc The Hospital for Sick Chidren

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Responsible Party: Upton Allen, Chief, division of infectious diseases, department of pediatrics, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02624349     History of Changes
Other Study ID Numbers: 1000037024
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Vaccines
Immunologic Factors
Physiological Effects of Drugs