Pneumococcal polysaccharide serotypes (23-valent) for Vaccination response

Inclusion criteria

• {"criterion_text":"- recipient of a kidney transplant who has participated in the study: ‘Tacrolimus monotherapy in immunologically low-risk kidney transplant recipients: a pilot randomized-controlled study’, NL46834.078.14.\n- able to give written informed consent"}

Exclusion criteria

• {"criterion_text":"- A potential subject who is unable to give written informed consent will be excluded from participation in this study:"}

Primary endpoints

• {"endpoint_text":"- a. Renal function and proteinuria. (creatinin and CKD-EPI; urine spot protein/ creatinine)\n- b. Patient survival.\n- c. Rejection episodes.\n- d. Infectious complications: opportunistic infections, use of antibiotics.\n- e. Malignancy o Skin (diagnosed via routine dermatology check-up) o Non-skin.","definition_or_measurement_approach":"a. Measured by creatinine and CKD-EPI; urine spot protein/creatinine. b. Patient survival (all-cause). c. Recorded rejection episodes. d. Recorded infectious complications including opportunistic infections and antibiotic use. e. Malignancy: skin malignancy diagnosed via routine dermatology check-up; non-skin malignancies recorded as reported."}

Secondary endpoints

• {"endpoint_text":"- Determination of donor-specific antibodies using Luminex single-antigen beads 4, 6 and 10 years after transplantation.","definition_or_measurement_approach":"Determination using Luminex single-antigen beads at years 4, 6 and 10 after transplantation."}
• {"endpoint_text":"- Quantification of pneumococcal vaccination response 3 and 5 years after pneumococcal vaccination (year 4 and 6 after kidney transplantation) with the 23-serotype polyvalent pneumococcal vaccine; and 3 weeks and one year after booster vaccination 5 years after the initial vaccination.","definition_or_measurement_approach":"Quantification of pneumococcal vaccination response at 3 and 5 years after vaccination (year 4 and 6 after transplantation) following 23-serotype vaccine; additional measurements 3 weeks and 1 year after booster given 5 years after initial vaccination."}

Netherlands

Earliest CTIS Part Ii Submission Date

16-01-2025

Latest Decision Or Authorization Date

27-01-2025

Processing Time Days

11

Number Of Sites

1

Number Of Participants

66

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands