Overview

This trial is active, not recruiting.

Conditions kidney transplantation, liver transplantation
Treatments prevenar13, pneumovax
Phase phase 4
Sponsor Helsinki University Central Hospital
Collaborator Tampere University Hospital
Start date January 2013
End date December 2016
Trial size 182 participants
Trial identifier NCT01781871, HUCH

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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
prevenar13
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
(Active Comparator)
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
pneumovax
0.5ml Pneumovax injected intramuscularly at day 1.
(Experimental)
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 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
(Active Comparator)
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.
pneumovax
0.5ml Pneumovax injected intramuscularly at day 1.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
vaccination reactions
time frame: from vaccination upto 1 week
rejection
time frame: at 1 and 2 months after the vaccination

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title 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
Principal investigator Veli-Jukka Anttila, MD,PhD,Docent
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Helsinki University Central Hospital.