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Safety and Immunogenicity of Human Papillomavirus (HPV) Vaccine in Solid Organ Transplant Recipients

NCT00677677 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-01-01

No results posted yet for this study

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 men, the virus can cause warts of the anal and genital areas. Men can also sexually transmit the virus to their partners. A patient who has had an organ transplant is at higher risk of infections as well as cancers because of the lifelong immune suppressive medications. HPV vaccination is effective in the prevention of cervical cancer and is now recommended for all females aged 9-26 years by Alberta Health and Wellness and the Canadian National Advisory Committee on Immunization (NACI). However, how well the vaccine works in transplant patients is not known.

This study is being done to look at response of the immune system to HPV vaccine in men and women up to the age of 35 who have had an organ transplant. Men are also included in this study because they have the potential to get anal / genital warts and transmit the virus to their partners. The total duration of the study is three years. Fifty female and male solid organ transplant recipients (lung, heart, liver, kidney, pancreas, small bowel or combined organ transplants) on immunosuppression will be enrolled in the study.

Conditions

  • Transplant

Interventions

BIOLOGICAL

Human papillomavirus quadrivalent vaccine

Patients meeting the inclusion / exclusion criteria will be enrolled from outpatient transplant clinics. Upon enrolment, baseline serum will be obtained and patients will be given the first dose of vaccine. Two months later, serum will again be obtained and the second dose of vaccine will be administered. Finally, at month 6, serum will be obtained and the third dose of vaccine will be given. The final serum samples will be collected at months 7, 12 and 36. At 48 hours and 7 days after each vaccination, patients will be contacted by telephone for local and systemic adverse effect reporting.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Deepali Kumar, MD · University of Alberta

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-04-30
Completion
2012-12-31

Countries

  • Canada

Study Locations

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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 NCT00677677 on ClinicalTrials.gov