Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients

Study Overview
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Brief Summary
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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.

Official Title
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Immunogenicity of Repeated Dose 13-valent Pneumococcal Conjugate Vaccine Compared to the Existing Recommended Protocol of Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients

Conditions
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Kidney Transplantation, Liver Transplantation

Intervention / Treatment
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* Biological: Prevenar13
* Biological: Pneumovax


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: consecutive new kidney or liver transplantation in our center kidney or liver retransplantation in our center Exclusion Criteria: Age < 18 years Previous Pneumococcal vaccination < 3 years ago Febrile illness at the time of vaccination Any sign of graft failure or rejection at the time of vaccination Splenectomy Pregnancy Critically ill patient due to any cause, including terminal uncompensated liver disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevenar13<br>68 kidney transplant patients vaccinated with Prevenar13 as they enter the transplant waiting list. Pre- and postvaccination serotype specific ELISA and OPA measured. Revaccination at 6 months after the transplantation with Prevenar13, again pre- and postvaccination serotype specific ELISA and OPA measured | Biological: Prevenar13<br>* Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.<br>|
| Active Comparator: Pneumovax<br>68 kidney transplant patients vaccinated with Pneumovax as they enter the transplant waiting list, serotype specific ELISA and OPA measured before and after the vaccination. At six and seven months after transplantation ELISA and OPA measured parallel to the experimental group | Biological: Pneumovax<br>* 0.5ml Pneumovax injected intramuscularly at day 1.<br>|
| Experimental: liver Prevenar13<br>30 liver transplant patients vaccinated with Prevenar13 once they enter the transplant waiting list. Serotype specific ELISA and OPA measured before and after the vaccination. Revaccinated with Prevenar13 at 6 months after the transplantation. ELISa and OPA measured pre- and postvaccination. | Biological: Prevenar13<br>* Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.<br>|
| Active Comparator: liver Pneumovax<br>30 liver transplant patients vaccinated with Pneumovax once they enter the transplant waiting list. Serotype specific ELISA and OPA measured pre- and postvaccination. At 6 and 7 months posttransplant ELISA and OPA measured parallel to the experimental group. | Biological: Pneumovax<br>* 0.5ml Pneumovax injected intramuscularly at day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination |  | 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 |  | baseline and 4 weeks after the second vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vaccination reactions | Questionaire and phone interview assessment of vaccination reactions and adverse effects. | from vaccination upto 1 week | 
| rejection | Urine analyses and creatinine measurement with kidney transplant patients. Alanine aminotransferase measurement with liver transplant patients. | at 1 and 2 months after the vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumococcal vaccination, immunogenicity, solid organ transplant