Clinical trial NCT02576145: A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
Official title: Immune Response to Neoantigen and Recall Antigen in Pediatric Renal Transplant Recipients Treated With the IL-2R Alfa Monoclonal Antibody, Daclizumab (Zenapax®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 11
Sex: ALL
Minimum age (years): 2
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.


Eligibility criteria: Inclusion Criteria:

* Primary renal transplant recipients between 2 and 19 years of age
* Receiving or have received daclizumab in the previous 4-18 months
* Receiving or have received daclizumab less than (\<) 24 hours pretransplant and additional courses every other week
* Single organ recipients (kidney only)
* Previous vaccination with tetanus toxoid (TT) prior to transplant
* Receiving a maintenance immunosuppression regimen of a calcineurin inhibitor, mycophenolate mofetil, and prednisone (or equivalent corticosteroid)

Exclusion Criteria:

* Received intravenous gamma globulin or a TT vaccination since transplant
* Experienced rejection within 3 months of receiving study vaccinations and/or treated with lymphocyte preparation or methylprednisolone to reverse suspected acute rejection within 3 months of receiving study vaccinations
* Received any vaccine within 30 days of receiving study vaccinations
* Received plasmapheresis treatment or growth hormone treatment since transplant

Primary outcomes:
measure: Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization
timeFrame: Baseline and Day 43 or Day 57
Secondary outcomes:
measure: Number of Participants Who Developed a Positive Cellular Response to KLH Immunization
timeFrame: Baseline, Day 22, Day 29, Day 43, and Day 57
measure: Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization
timeFrame: Baseline, Day 22, Day 29, Day 43 and Day 57
measure: Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT)
timeFrame: Baseline, Day 22, Day 29, Day 43 and Day 57
measure: Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT)
timeFrame: Baseline, Day 22, Day 29, Day 43 and Day 57
measure: Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations
timeFrame: Baseline, Day 22, Day 29, Day 43 and Day 57
measure: Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization
timeFrame: Up to Day 252
measure: Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response
timeFrame: up to Day 252
measure: Geometric Mean Antibody Concentrations for KLH (IgM and IgG) and TT (IgG)
timeFrame: Screening, Day 22, Day 29, Day 43 and Day 57
measure: Mean Percent Expression of 2A3/CD25+ Antibody
timeFrame: Screening, Day 29, Day 57 and Day 168
measure: Mean Percent Expression of CD3, CD4, and CD8
timeFrame: Days 1, 22, 29, 43 and 57
measure: Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+
timeFrame: Days 1, 29 and 57
measure: Percentage of Participants With Positive Antibody Response to KLH Immunization at Month 6
timeFrame: Month 6
measure: Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response
timeFrame: Up to Day 252
measure: Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization
timeFrame: Day 1 and Day 29
measure: Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)
timeFrame: Up to Month 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Missouri
city: Portland
country: United States
state: Oregon
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: