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
Intervention: Quadrivalent HPV for types 6, 11, 16 and 18
Intervention description: 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.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
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)
Masking description: No masking.
Enrollment: 25.0
Sex: All
Minimum age: 9 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Gardasil; HPV; transplant; adolescent; prevention; vaccine; immunogenicity; vaccination

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.
    

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