Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients (SOT13)

Helsinki University Central Hospital (HUCH)

Status and phase: Completed; Phase 4

Conditions: Liver Transplantation; Kidney Transplantation

Treatments: Biological: Pneumovax; Biological: Prevenar13

Study type: Interventional

Funder types: Other

Identifiers

NCT01781871

HUCH

Details and patient eligibility

About

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.

Enrollment: 182 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 4 patient groups

Prevenar13

Experimental group

Description:

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

Treatment:

Biological: Prevenar13

Pneumovax

Active Comparator group

Description:

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

Treatment:

Biological: Pneumovax

liver Prevenar13

Experimental group

Description:

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.

Treatment:

Biological: Prevenar13

liver Pneumovax

Active Comparator group

Description:

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.

Treatment:

Biological: Pneumovax