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

NCT ID: NCT03100682

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-18

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Paediatric Kidney or Liver Transplantation Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Heidelberg

OTHER

Sponsor Role lead

Responsible Party

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PD Dr. med. Britta Hoecker

Privatdozentin Dr. med. Britta Hoecker

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Britta Hoecker, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital of Heidelberg

Locations

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University Children's Hospital

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Britta Hoecker, MD

Role: CONTACT

+49 6221 564002

Facility Contacts

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Britta Hoecker, MD

Role: primary

Other Identifiers

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HPVaxResponse Study

Identifier Type: -

Identifier Source: org_study_id

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