Severe Pneumococcal disease, such as bacteremia, meningitis and pneumonia, cause significant morbidity and mortality in both otherwise healthy adult population and in the immunocompromised patients. The incidence rate of invasive pneumococcal disease is considerably higher among organ transplant patients than in healthy individuals. Routine immunization with Pneumococcal vaccine is recommended pretransplant and once 3-5 years after the transplantation. The efficacy and immunogenicity of Pneumococcal polysaccharide vaccine(Pneumovax®) is suboptimal in this patient group. The conjugate Pneumococcal vaccine has been shown to be more immunogenic and safe in some other subgroups of immunocompromised patients. We intend to compare the immunogenicity of repeated dose 13-valent Pneumococcal conjugate vaccine (Prevenar13®)to the existing recommended protocol of Pneumococcal polysaccharide vaccine (Pneumovax®) in adult kidney and liver transplant patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
182
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
0.5ml Pneumovax injected intramuscularly at day 1.
Helsinki University Central Hospital
Helsinki, HUS, Finland
Heikki Saha
Tampere, Finland
Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination
Time frame: baseline and 4 weeks after the first vaccination
Change from baseline serum serotype specific IgG antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the second Prevenar vaccination
Time frame: baseline and 4 weeks after the second vaccination
vaccination reactions
Questionaire and phone interview assessment of vaccination reactions and adverse effects.
Time frame: from vaccination upto 1 week
rejection
Urine analyses and creatinine measurement with kidney transplant patients. Alanine aminotransferase measurement with liver transplant patients.
Time frame: at 1 and 2 months after the vaccination
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