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

Chronic Kidney Disease Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03100682
• Other study ID #: HPVaxResponse Study
• Status: Recruiting
• Start date: March 18, 2017
• Est. completion date: December 2022

Study information

• Verified date: May 2021
• Source: University Hospital Heidelberg
• Contact: Britta Hoecker, MD
• Phone: +49 6221 564002
• Email: britta.hoecker[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Paediatric Kidney or Liver Transplantation
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Germany	University Children's Hospital	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immune Response to HPV vaccine	HPV vaccine antibodies	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.