Clinical trial NCT01101750: Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Cancer
Hpv
Warts
Keywords: Gardasil
HPV
transplant
adolescent
prevention
vaccine
immunogenicity
vaccination
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2010-04-12
Enrollment: 25
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: OTHER

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 (www.labrepco.com). The lab we will use to process our antibody titers is PPD Labs (www.ppdi.com). 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects Showing Seroconversion to All HPV Four Serotypes
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
Study officials:
affiliation: Washington Hospital Center, Georgetown University Hospital
name: Veronica Gomez-Lobo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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