Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?

NCT01101750 | Completed Phase 4 Results

• 1 other identifier: GardasilMerckGomez-Lobo
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

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

Cervical Cancer; Hpv; Warts

Keywords

Gardasil; HPV; transplant; adolescent; prevention; vaccine; immunogenicity; vaccination

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Showing Seroconversion to All HPV Four Serotypes

  7 months

Study Arms (1)

Liver and Kidney Transplant Patient Arm

OTHER

Standard of Care Intervention: Participants on this arm receive Gardasil vaccine and have a history of liver or kidney transplant.

Biological: Quadrivalent HPV for types 6, 11, 16 and 18

Interventions

Quadrivalent HPV for types 6, 11, 16 and 18 BIOLOGICAL

Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6. Serum samples on day one, month 3 and month 7.

Also known as: Gardasil Vaccine

Liver and Kidney Transplant Patient Arm

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female patients age 9-17 who have undergone liver or kidney transplant are on stable immunosuppressant doses for greater than 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (17)

• Danzinger-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 BACKGROUND

• Kasiske 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 BACKGROUND

• De 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 BACKGROUND

• D'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 BACKGROUND

• Badawi 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 BACKGROUND

• Penn I. Occurrence of cancers in immunosuppressed organ transplant recipients. Clin Transpl. 1998:147-58.

  PMID: 10503093 BACKGROUND

• Villa 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.

  PMID: 17117182 BACKGROUND

• Joura EA, Kjaer SK, Wheeler CM, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Lehtinen M, Steben M, Bosch X, Dillner J, Kurman RJ, Majewski S, Munoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Lu S, Vuocolo S, Hesley TM, Haupt RM, Barr E. HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine. 2008 Dec 9;26(52):6844-51. doi: 10.1016/j.vaccine.2008.09.073. Epub 2008 Oct 16.

  PMID: 18930097 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

• Villa LL. Overview of the clinical development and results of a quadrivalent HPV (types 6, 11, 16, 18) vaccine. Int J Infect Dis. 2007 Nov;11 Suppl 2:S17-25. doi: 10.1016/S1201-9712(07)60017-4.

  PMID: 18162241 BACKGROUND

• Carey W, Pimentel R, Westveer MK, Vogt D, Broughan T. Failure of hepatitis B immunization in liver transplant recipients: results of a prospective trial. Am J Gastroenterol. 1990 Dec;85(12):1590-2.

  PMID: 2252022 BACKGROUND

• Guidelines for vaccination of solid organ transplant candidates and recipients. Am J Transplant. 2004 Nov;4 Suppl 10:160-3. doi: 10.1111/j.1600-6135.2004.00737.x. No abstract available.

  PMID: 15504229 BACKGROUND

• Loinaz C, de Juanes JR, Gonzalez EM, Lopez A, Lumbreras C, Gomez R, Gonzalez-Pinto I, Jimenez C, Garcia I, Fuertes A. Hepatitis B vaccination results in 140 liver transplant recipients. Hepatogastroenterology. 1997 Jan-Feb;44(13):235-8.

  PMID: 9058151 BACKGROUND

• Duca P, Del Pont JM, D'Agostino D. Successful immune response to a recombinant hepatitis B vaccine in children after liver transplantation. J Pediatr Gastroenterol Nutr. 2001 Feb;32(2):168-70. doi: 10.1097/00005176-200102000-00014.

  PMID: 11321387 BACKGROUND

• Lefebure AF, Verpooten GA, Couttenye MM, De Broe ME. Immunogenicity of a recombinant DNA hepatitis B vaccine in renal transplant patients. Vaccine. 1993;11(4):397-9. doi: 10.1016/0264-410x(93)90278-6.

  PMID: 8470423 BACKGROUND

• Rendi-Wagner P, Kundi M, Stemberger H, Wiedermann G, Holzmann H, Hofer M, Wiesinger K, Kollaritsch H. Antibody-response to three recombinant hepatitis B vaccines: comparative evaluation of multicenter travel-clinic based experience. Vaccine. 2001 Feb 28;19(15-16):2055-60. doi: 10.1016/s0264-410x(00)00410-2.

  PMID: 11228377 BACKGROUND

• Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.

  PMID: 17079588 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Papillomavirus Infections; Warts

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Veronica Gomez-Lobo, MD
• Organization: MedStar Health Research Institute

veronica.gomez-lobo@medstar.net

202-877-4099

Study Officials

• Veronica Gomez-Lobo, MD

  Washington Hospital Center, Georgetown University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: No masking.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective study to evaluate immune response to the Gardisil vaccine in patients with a history of liver transplant and patients with a history of kidney transplant.

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 12, 2010
• Study Start: May 1, 2010
• Primary Completion: January 20, 2012
• Study Completion: December 14, 2012
• Last Updated: January 5, 2021
• Results First Posted: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)