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

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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03100682

Enrollment

140

Registered

2017-04-04

Start date

2017-03-18

Completion date

2022-12-31

Last updated

2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Paediatric Kidney or Liver Transplantation

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

9 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Immune Response to HPV vaccine	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

Countries

Germany

Contacts

Primary ContactBritta Hoecker, MD

britta.hoecker@med.uni-heidelberg.de+49 6221 564002

Outcome results