Clinical trial · Interventional
Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?
Immunogenicity Of A Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, And 18) L1 Virus-Like Particle Vaccine In Male And Female Adolescent Transplant Recipients.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to understand if children with liver and kidney transplants develop the antibodies from the Gardasil vaccine. The Gardasil vaccine protects against Human Papilloma Virus (HPV) types 16 and 18, which cause most types of cancers of the cervix, vagina and vulva. It also protects against Human Papilloma Virus types 6 and 11, which cause genital warts in some people. Gardasil has been approved by the Food and Drug Administration and is recommended for girls and women from ages 9-26 for the prevention of some types of cancer of the cervix, vagina and vulva as well as preventing some types of genital warts. In males that are 9-26 years old, the FDA has approved its use for prevention of some types of genital warts. The Gardasil vaccine is made from a virus like particle and does not contain any live virus. Children with an allergy to yeast should not receive the vaccine since some components of the vaccine are made from yeast. People who have undergone organ transplant are at increased risk of of developing genital warts and cancers related to HPV when compared to the general population. The American Society of Transplantation and the American Society of Transplant Surgeons recommend the vaccine for people with transplants. Studies of other vaccines like Hepatitis B have shown children after transplant have less of a response to this vaccine and are not immune to the Hepatitis B virus. We are interested in seeing if your child will form antibodies (immune response) to the Gardasil vaccine. Your child is being asked to be in the study because he or she is between the ages of 9-17 and has undergone a liver or kidney transplant more than 6 months ago and does not have any signs of organ rejection.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Hpv | — | UNRESOLVED | — |
| Warts | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quadrivalent HPV for types 6, 11, 16 and 18 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Liver and Kidney Transplant Patient Arm
- description
- Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant.
- interventionNames
- Biological: Quadrivalent HPV for types 6, 11, 16 and 18
Primary outcomes (1)
- measure
- Number of Subjects Showing Seroconversion to All HPV Four Serotypes
- timeFrame
- 7 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 9 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients age 9-17 who have undergone liver or kidney transplant are on stable immunosuppressant doses for greater than 6 months Exclusion Criteria: * Previous vaccination with Gardasil or Cervarix * Allergy to Gardasil or components of Gardasil including yeast * Diagnosis of HIV or cancer * Pregnancy * Blood transfusion 6 months prior to initiation of Gardasil vaccine protocol
References
Publications (17)
- BACKGROUNDDanzinger-Isakov L, Kumar D; AST Infectious Diseases Community of Practice. Guidelines for vaccination of solid organ transplant candidates and recipients. Am J Transplant. 2009 Dec;9 Suppl 4:S258-62. doi: 10.1111/j.1600-6143.2009.02917.x. No abstract available. PMID 20070687
- BACKGROUNDKasiske BL, Snyder JJ, Gilbertson DT, Wang C. Cancer after kidney transplantation in the United States. Am J Transplant. 2004 Jun;4(6):905-13. doi: 10.1111/j.1600-6143.2004.00450.x. PMID 15147424
- BACKGROUNDDe Vuyst H, Clifford GM, Nascimento MC, Madeleine MM, Franceschi S. Prevalence and type distribution of human papillomavirus in carcinoma and intraepithelial neoplasia of the vulva, vagina and anus: a meta-analysis. Int J Cancer. 2009 Apr 1;124(7):1626-36. doi: 10.1002/ijc.24116. PMID 19115209
- BACKGROUNDD'Souza G, Kreimer AR, Viscidi R, Pawlita M, Fakhry C, Koch WM, Westra WH, Gillison ML. Case-control study of human papillomavirus and oropharyngeal cancer. N Engl J Med. 2007 May 10;356(19):1944-56. doi: 10.1056/NEJMoa065497. PMID 17494927
- BACKGROUNDBadawi H, Ahmed H, Ismail A, Diab M, Moubarak M, Badawy A, Saber M. Role of human papillomavirus types 16, 18, and 52 in recurrent cystitis and urinary bladder cancer among Egyptian patients. Medscape J Med. 2008;10(10):232. Epub 2008 Oct 8. PMID 19099026
- BACKGROUNDPenn I. Occurrence of cancers in immunosuppressed organ transplant recipients. Clin Transpl. 1998:147-58. PMID 10503093
- BACKGROUNDVilla LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, Olsson SE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, Krogh Gv, Lehtinen M, Malm C, Tamms GM, Giacoletti K, Lupinacci L, Railkar R, Taddeo FJ, Bryan J, Esser MT, Sings HL, Saah AJ, Barr E. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer. 2006 Dec 4;95(11):1459-66. doi: 10.1038/sj.bjc.6603469. Epub 2006 Nov 21.