CClinicalTrials.gg
Status unknownNCT03100682Updated Jun 2, 2021

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

An observational study in Paediatric Kidney or Liver Transplantation and Chronic Kidney Disease, sponsored by University Hospital Heidelberg. Status unknown at 1 site in Germany. Open to participants aged 9 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.

Sponsored by University Hospital Heidelberg · Observational

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
9 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Paediatric Kidney or Liver Transplantation
  • Chronic Kidney Disease
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In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 140 is below the median of 192 across 1,033 observational studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University Hospital Heidelberg is the lead sponsor of 175 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Paediatric Kidney and/or Liver transplant recipients Paediatric patients with CKD

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Immune Response to HPV vaccine

    HPV vaccine antibodies

    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.

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Study locations

1 of 1 sites recruiting
  • University Children's Hospital
    Heidelberg, 69120, Germany
    • Britta Hoecker, MD · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03100682
Lead sponsor
University Hospital Heidelberg
Responsible party
PD Dr. med. Britta Hoecker (Privatdozentin Dr. med. Britta Hoecker, University Hospital Heidelberg) — Principal investigator
First posted
Apr 4, 2017
Start date
Mar 18, 2017
Primary completion
Mar 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jun 2, 2021

Study contacts

Britta Hoecker, MD
Contact
britta.hoecker@med.uni-heidelberg.de
+49 6221 564002
Britta Hoecker, MD
principal investigator · University Children's Hospital of Heidelberg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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