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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101750
Recruitment Status : Unknown
Verified February 2011 by Medstar Health Research Institute.
Recruitment status was:  Recruiting
First Posted : April 12, 2010
Last Update Posted : February 10, 2011
Merck Sharp & Dohme Corp.
Information provided by:
Medstar Health Research Institute

Tracking Information
First Submitted Date  ICMJE April 5, 2010
First Posted Date  ICMJE April 12, 2010
Last Update Posted Date February 10, 2011
Study Start Date  ICMJE May 2010
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
Seroconversion rates to quadrivalent HPV vaccine in kidney and liver transplant adolescents when compared to healthy historical controls [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01101750 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2010)
Side effects of quadrivalent HPV vaccine in kidney and liver transplant adolescents when compared to healthy historical controls [ Time Frame: 3 years ]
We will document the side effects of the participants and compare them to the frequency and duration of the side effects experienced by the healthy controls
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?
Official Title  ICMJE 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.
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.

Detailed Description

Currently Merck manufactures the HPV (types 6, 11, 16, and 18) L1 virus like particle vaccine and a description has been reported previously. (18) Merck will supply the vaccine, which will be stored as directed by the manufacturer. The vaccine will be stored at the Medstar Research Institute (Women and Infants Research Services) It will be administered by intramuscular injection (0.5 mL) into the upper arm or thigh by the research nurse (Sarah Duwel, RN or a nurse working under supervision) in the transplant clinic.

Participants will be given a form to fill out regarding allergic prior to vaccination. After the research nurse reviews the form with the patient and their guardian, an immunization or blood collection will be performed. Participants will receive a full dose vaccine on day 1, at month 2 (± 3 weeks), and at month 6 (± 3 weeks). All participants will be required to be afebrile (oral temperature <37.8° C) within 24 hours before each injection.

All female participants will undergo urine pregnancy testing and will not be vaccinated if found to be pregnant. Female participants with a positive urine pregnancy test will be informed confidentially of their test results by the study nurse and will be referred to an OB/GYN for further care.

Serum samples will be obtained from all participants on day 1, at month 3, and at month 7. Samples will be de-identified and stored at -20°C or below and anti-HPV levels will be determined using an HPV type-specific competitive Luminex xMAP-based immunoassay (cLIA). (18) Merck will make arrangements for the labs tests. This assay measures only neutralizing anti-HPV antibodies, rather than the broad assortment of vaccine-induced anti-HPV antibodies. Antibody levels will be expressed as milliMerck units (mMU) per milliliter. The lower limits of detection for the anti-HPV 6, 11, 16, and 18 cLIAs are 4.1 mMU6/mL, 3.0 mMU11/mL, 10.2 mMU16/mL, and 2.9 mMU18/mL, respectively. Assay precision is estimated to be 21.7%, 20.4%, 23.0%, and 15.9% for the anti-HPV 6, 11, 16, and 18 cLIAs respectively. Participants will be considered anti-HPV 6, 11, 16, or 18 seropositive when their anti-HPV antibody titers are 20 mMU6/mL, 16 mMU11/mL, 20 mMU16/mL, or 24 mMU18/mL, respectively.

Blood collection supplies will be obtained from a lab vendor Laprepco ( The lab we will use to process our antibody titers is PPD Labs ( De-identified blood samples will be stored by the research nurse at Mesdstar Research Institute until they are able to be shipped to the PPD lab. Our research nurses are trained in Environmental and Health Safety training based on Medstar Research Institution requirements. Antibody titers results will be mail directly to Dr. Gomez-Lobo.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Cervical Cancer
  • Hpv
  • Warts
Intervention  ICMJE Biological: Quadrivalent HPV for types 6, 11, 16 and 18
Gardasil 0.5ml IM injection on day one, month 2, and month 6. Serum samples on day one, month 3 and month 7
Other Name: Gardasil Vaccine
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 8, 2010)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2014
Estimated Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01101750
Other Study ID Numbers  ICMJE GardasilMerckGomez-Lobo
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Veronica Gomez-Lobo, Director, Associate Clinical Professor, Section of Pediatric and Adolescent Ob/Gyn Department of Obstetrics and Gynecology, Washington Hospital Center
Study Sponsor  ICMJE Medstar Health Research Institute
Collaborators  ICMJE Merck Sharp & Dohme Corp.
Investigators  ICMJE
Principal Investigator: Veronica Gomez-Lobo, MD Washington Hospital Center, Georgetown University Hospital
PRS Account Medstar Health Research Institute
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP