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

Phase 4

Completed

• Conditions: Kidney Transplantation; Liver Transplantation
• Interventions: Biological: Pneumovax; Biological: Prevenar13

• Registration Number: NCT01781871
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-22
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-30
• Study First Posted: 2013-02-01
• Status Verified: 2017-10
• Primary Completion: 2017-10-04
• Study Completion: 2017-10-04
• Last Update Submitted: 2017-10-04
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pneumovax	Pneumovax	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
liver Prevenar13	Prevenar13	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.
Prevenar13	Prevenar13	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
liver Pneumovax	Pneumovax	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.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Helsinki University Central Hospital; 🇫🇮 Helsinki, HUS, Finland

Heikki Saha; 🇫🇮 Tampere, Finland