Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?
Condition: Cervical Cancer; Hpv; Warts
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Quadrivalent HPV for types 6, 11, 16 and 18
Intervention type(s): Biological
Intervention description(s): 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.
Other intervention name(s): Gardasil Vaccine
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Gardasil; HPV; transplant; adolescent; prevention; vaccine; immunogenicity; vaccination