A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)

Immune Response to Neoantigen and Recall Antigen in Pediatric Renal Transplant Recipients Treated With the IL-2R Alfa Monoclonal Antibody, Daclizumab (Zenapax®)

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.

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