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Trial record 2 of 303 for:    Recruiting, Not yet recruiting, Available Studies | Pediatrics

Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT03100682
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
PD Dr. med. Britta Hoecker, University Hospital Heidelberg

Brief Summary:
Due to their immunosuppressive therapy, solid-organ transplant (SOT) recipients bear a 10 to 100 times higher risk of human papillomavirus (HPV)-associated malignancies than healthy individuals. The objectives of this observational, non-interventional multi-national, multi-centre research project are to gain an insight into current HPV vaccination strategies and to investigate the immune response to different routinely administered HPV vaccines in European paediatric SOT candidates and immunocompromised transplant recipients, enabling patients at risk of vaccination failure to be identified.

Condition or disease
Paediatric Kidney or Liver Transplantation Chronic Kidney Disease

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevention of Human Papillomavirus (HPV) Infection in Paediatric Kidney and Liver Transplant Recipients and in Paediatric Patients With Advanced Chronic Kidney Disease: a Prospective, Observational Multi-centre Vaccine Surveillance Study (HPVaxResponse Study)
Actual Study Start Date : March 18, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Immune Response to HPV vaccine [ Time Frame: Change of immune response from baseline (prior to vaccination) to 4-12 weeks after vaccination and to 18+- 3 months after vaccination will be assessed. ]
    HPV vaccine antibodies


Biospecimen Retention:   Samples Without DNA
Serum rest material


Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Paediatric Kidney and/or Liver transplant recipients Paediatric patients with CKD
Criteria

Inclusion Criteria:

  • Paediatric Kidney and/or Liver transplant recipients
  • Paediatric patients with CKD
  • Who receive HPV vaccination according to country-specific vaccine schedule

Exclusion Criteria:

  • No HPV vaccination according to country-specific vaccine schedule
  • No written informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100682


Contacts
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Contact: Britta Hoecker, MD +49 6221 564002 britta.hoecker@med.uni-heidelberg.de

Locations
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Germany
University Children's Hospital Recruiting
Heidelberg, Germany, 69120
Contact: Britta Hoecker, MD         
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
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Principal Investigator: Britta Hoecker, MD University Children's Hospital of Heidelberg

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Responsible Party: PD Dr. med. Britta Hoecker, Privatdozentin Dr. med. Britta Hoecker, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT03100682     History of Changes
Other Study ID Numbers: HPVaxResponse Study
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency