Status:
COMPLETED
Safety and Immunogenicity of Human Papillomavirus (HPV) Vaccine in Solid Organ Transplant Recipients
Lead Sponsor:
University of Alberta
Conditions:
Transplant
Eligibility:
All Genders
18-35 years
Phase:
PHASE3
Brief Summary
Human papillomavirus (HPV) affects a significant number of transplant patients. In women, human papillomavirus (HPV) causes genital warts, pre-cancerous areas of the cervix, and cervical cancer. In me...
Detailed Description
Cervical cancer affects a significant proportion of the female population. In Canada, it is estimated that there will be 1,350 new diagnoses of cervical cancer in 2007 and 390 deaths \[1\]. Human papi...
Eligibility Criteria
Inclusion
- Male and female Age ≥ 18 and ≤ 35
- Solid Organ Transplant ≥ 3 months post-transplant
- Outpatient status
Exclusion
- Unable to comply with protocol
- Previous HPV vaccination
- Anticoagulation (that precludes intramuscular injection)
- Therapy for acute rejection in the past 2 weeks
- Febrile illness in the past 2 weeks
- Active CMV infection
- History of anogenital warts or cervical intraepithelial neoplasia or cervical cancer
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00677677
Start Date
May 1 2008
End Date
December 1 2012
Last Update
January 1 2015
Active Locations (1)
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1
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G-2E1