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

Completed · Phase 4

Conditions studied: Cervical Cancer, Hpv, Warts

In brief

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.

Key facts

Study ID

NCT01101750

Run by

Medstar Health Research Institute

People needed

25

Starts

2010-05-01

Expected to finish

2012-12-14

Last updated by the study team

2021-01-05

Who can join

Age: 9 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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