Phase 4
N=25
Does the HPV Vaccine Cause the Same Response in Adolescent Kidney and Liver Transplant Patients as in Healthy Controls?
Cervical Cancer · Hpv · Warts
Bottom Line
View on ClinicalTrials.gov: NCT01101750 ↗Enrolled (actual)
25
Serious AEs
12.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Subjects Showing Seroconversion to All HPV Four Serotypes — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Quadrivalent HPV for types 6, 11, 16 and 18 (Biological)
- Age
- Pediatric · 9+ yrs
- Sex
- All
- Sponsor
- Medstar Health Research Institute
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Showing Seroconversion to All HPV Four Serotypes |
9 | — |
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
Data sourced from ClinicalTrials.gov (NCT01101750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.