Immune Response to Human Papilloma Virus vaccination in Patients with Chronic Renal Failure

Conditions: Cervical cancer
MedDRA version: 14.1Level: LLTClassification code 10071147Term: Human papilloma virus immunizationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-000445-12-DK

Lead Sponsor: Department off Infectious Diseases, Aarhus University Hospital Skejby, Denmark

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion criteria
Transplant candidates:
•Signed Written Informed Consent.
•Men and women aged 18-70 at inclusion
•Chronic renal failure with estimated GRF (e-GFR<30 ml/min)
•No treatment with immunosuppressive agents within 3 months prior to inclusion.
•Assessed as transplant candidate” by MD specialised in Nephrology.

Renal kidney transplant recipients:
•Signed Written Informed Consent.
•Men and women aged 18-70 at inclusion
•Transplantation minimum 1 year prior to inclusion
•First time of transplantation.
•Kidney function stable and no episodes of rejection 9 months prior to inclusion

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18

Exclusion Criteria

•Pregnancy (positive pregnancy test)
•Nursing women
•Women of childbearing potential, unwilling to use effective contraception throughout the study
•History of hypersensitivity to vaccines
•Known allergy to one or more of the vaccine components
•Any medical, psychiatric and/or social reason including alcohol/drug abuse which in the opinion of the investigator, renders the candidate inappropriate for participation in the study
•Previously received a human papilloma virus vaccine.
•Active cancer disease