- 6/1/19 - 1 form, 2 itemgroups, 10 items, 1 language
Itemgroups: Inclusion Criteria, Exclusion Criteria
Immunosenescence and Hepatitis B Virus (HBV) Vaccine Efficacy in Chronic Renal Disease Patient; ODM derived from: https://clinicaltrials.gov/show/NCT02375711 Brief Summary: The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency. Detailed Description: The risk of infection with hepatitis B during exposure to blood is high (30% against 1.8% for Hepatitis C Virus and HIV 1%) and dialysis patients are a population at risk. Vaccination against this virus, which is very effective in the general population (vaccine response: 90 to 95%), is highly recommended in dialysis patients. However, numerous studies have shown that HBV vaccination was less effective in patients with chronic renal disease than in the general population. The reasons for low vaccine response are poorly understood. However, recent data suggest that renal failure could induce accelerated immunosenescence. The aging of the immune system, or immunosenescence, is a complex and profound phenomenon of the immune system during life. The gradual reduction of the generation of naive T cells in the thymus is the major cause of immunosenescence. But this process is also associated with an accumulation of lymphocytes at the end of differentiation. In this context, the decrease in vaccine response and increased infections in renal insufficiency might be correlated, as in the elderly population, with the aging of the immune system. The aim of this study is to investigate the role of immunosenescence in the HBV vaccination response in patients with renal insufficiency. Vaccination against HBV is not performed for the purposes of the study, but due to the existing vaccine indication for the subject. Included patients receive vaccination as routine care according to the recommendations and the vaccination schedule recommended by the Health Authority.
- 2/28/19 - 1 form, 10 itemgroups, 51 items, 1 language
Itemgroups: ELIMINATION CRITERIA DURING THE STUDY, CONTRAINDICATIONS TO SUBSEQUENT VACCINATION, PRECAUTIONS, INFORMED CONSENT, DEMOGRAPHICS, ELIGIBILITY CHECK, INCLUSION CRITERIA, EXCLUSION CRITERIA, RANDOMISATION / TREATMENT ALLOCATION, GROUP HBV AT BIRTH
- 11/28/18 - 1 form, 9 itemgroups, 8 items, 1 language
Itemgroups: Absolute Contraindications, DTPw vaccines, GSK Biologicals' RotarixTM vaccine or its placebo, Local registered OPV, Relative Contraindications, DTPw vaccines, GSK Biologicals' RotarixTM or its placebo, Precautions for DTPw vaccines, DTPw-HBV vaccines should under no circumstances be administered intravenously
- 9/9/17 - 1 form, 17 itemgroups, 95 items, 1 language
Itemgroups: Informed consent, Demographics, Laboratory tests, Eligibility, Inclusion criteria, Exclusion Criteria, Smoking history, Alcohol consumption, Medical history, Disease, Urine sample, Pre-vaccination assessment, Vaccine administration, Vaccine administration, Vaccine administration, Vaccine administration, Serious adverse event - Post-vaccination observation
- 9/9/17 - 1 form, 14 itemgroups, 44 items, 1 language
Itemgroups: study continuation, Blood sample, Concomitant vaccination, Concomitant vaccination, Medication, Medication, Medical status, Disease, Follow-up Studies, serious adverse event, Pregnancy, Elimination criteria, Study conclusion, Investigator's signature