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

NCT00677677 | Completed Phase 3

• 1 other identifier: 7350
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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

Keywords

Lung transplant; Liver transplant; Kidney transplant; Pancreas transplant; HPV; Human Papillomavirus Quadrivalent Vaccine

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be a 2-fold rise in the type-specific HPV titer for at least one of the four sertypes contained in the vaccine at month 7.

  36 months

Secondary Outcomes (1)

• Vaccine adverse events including episodes of rejection up to 1 year after study enrolment. Immunogenicity at 36 months post-vaccination.

  36 months

Interventions

Human papillomavirus quadrivalent vaccine BIOLOGICAL

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.

Also known as: Gardasil

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female Age ≥ 18 and ≤ 35
• Solid Organ Transplant ≥ 3 months post-transplant
• Outpatient status

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G-2E1, Canada

Location

Related Publications (4)

• Barr E, Tamms G. Quadrivalent human papillomavirus vaccine. Clin Infect Dis. 2007 Sep 1;45(5):609-7. doi: 10.1086/520654. Epub 2007 Jul 25.

  PMID: 17682997 BACKGROUND

• FUTURE II Study Group. Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions. N Engl J Med. 2007 May 10;356(19):1915-27. doi: 10.1056/NEJMoa061741.

  PMID: 17494925 BACKGROUND

• Human papillomavirus infection. Am J Transplant. 2004 Nov;4 Suppl 10:95-100. doi: 10.1111/j.1600-6135.2004.00732.x. No abstract available.

  PMID: 15504222 BACKGROUND

• Kumar D, Unger ER, Panicker G, Medvedev P, Wilson L, Humar A. Immunogenicity of quadrivalent human papillomavirus vaccine in organ transplant recipients. Am J Transplant. 2013 Sep;13(9):2411-7. doi: 10.1111/ajt.12329. Epub 2013 Jul 9.

  PMID: 23837399 DERIVED

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

• Deepali Kumar, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: May 12, 2008
• First Posted: May 14, 2008
• Study Start: May 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: December 1, 2012
• Last Updated: January 1, 2015

Record last verified: 2014-12

Locations

CA (1)