Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01101750
Study type Interventional
Source Medstar Health Research Institute
Contact
Status Completed
Phase Phase 4
Start date May 2010
Completion date December 14, 2012

See also
  Status Clinical Trial Phase
Recruiting NCT06223308 - A Study Evaluating the Safety and Efficacy of HB0028 in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Terminated NCT03367871 - Combination Pembrolizumab, Chemotherapy and Bevacizumab in Patients With Cervical Cancer Phase 2
Active, not recruiting NCT04537156 - Efficacy, Immunogenicity and Safty Study of Recombinant Human Papillomavirus Vaccine(6,11,16,18,31,33,45,52,58 Type)(E.Coli) Phase 3
Recruiting NCT03668639 - Safety and Antiemetic Efficacy of Akynzeo Plus Dexamethasone During Radiotherapy and Concomitant Weekly Cisplatin Phase 2/Phase 3
Active, not recruiting NCT04242199 - Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors Phase 1
Withdrawn NCT04806945 - A Phase III Study to Evaluate Efficacy and Safety of First-Line Treatment With HLX10 + Chemotherapy in Patients With Advanced Cervical Cancer Phase 3
Active, not recruiting NCT04185389 - Long-Term Follow-Up of HPV FOCAL Participants
Withdrawn NCT03007771 - Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) Used for Mild Hyperthermia Phase 1
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Recruiting NCT05107674 - A Study of NX-1607 in Adults With Advanced Malignancies Phase 1
Completed NCT05120167 - Strategies for Endocervical Canal Investigation in Women With Abnormal Screening Cytology and Negative Colposcopy N/A
Recruiting NCT05483491 - KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer Phase 1
Recruiting NCT05736588 - Elimisha HPV (Human Papillomavirus) N/A
Completed NCT05862844 - Promise Women Project N/A
Recruiting NCT04934982 - Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) N/A
Recruiting NCT03876860 - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis N/A
Completed NCT03652077 - A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies Phase 1
Completed NCT00543543 - Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001) Phase 3
Terminated NCT04864782 - QL1604 Plus Chemotherapy in Subjects With Stage IVB, Recurrent, or Metastatic Cervical Cancer Phase 2/Phase 3
Recruiting NCT04226313 - Self-sampling for Non-attenders to Cervical Cancer Screening N/A