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

This study is currently recruiting participants.
Verified January 2013 by Helsinki University Central Hospital
Sponsor:
Collaborator:
Tampere University Central Hospital
Information provided by (Responsible Party):
Mari Eriksson, Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01781871
First received: November 22, 2012
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Liver Transplantation
 Biological: Prevenar13
Biological: Pneumovax
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • vaccination reactions [ Time Frame: from vaccination upto 1 week ] [ Designated as safety issue: Yes ]
    Questionaire and phone interview assessment of vaccination reactions and adverse effects.

  • rejection [ Time Frame: at 1 and 2 months after the vaccination ] [ Designated as safety issue: Yes ]
    Urine analyses and creatinine measurement with kidney transplant patients. Alanine aminotransferase measurement with liver transplant patients.


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevenar13
50 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
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
Active Comparator: Pneumovax
50 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
0.5ml Pneumovax injected intramuscularly at day 1.
Experimental: liver Prevenar13
25 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
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
Active Comparator: liver Pneumovax
25 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
0.5ml Pneumovax injected intramuscularly at day 1.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781871

Contacts
Contact: Mari Eriksson, MD +358504270205 mari.eriksson@hus.fi
Contact: Veli-Jukka Anttila, MD, PhD, Docent +358504271512 veli-jukka.anttila@hus.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, HUS, Finland, 00029
Contact: Mari Eriksson, MD     +358504270205     mari.eriksson@hus.fi    
Contact: Veli-Jukka Anttila, MD,PhD,Docent     +358504271512     veli-jukka.anttila@hus.fi    
Principal Investigator: Mari Eriksson, MD            
Heikki Saha Not yet recruiting
PL2000 Tampere, Finland, 33521
Contact: Heikki Saha, chief of ward     +3583311611     heikki.saha@pshp.fi    
Principal Investigator: heikki saha, chief of ward            
Sponsors and Collaborators
Helsinki University Central Hospital
Tampere University Central Hospital
Investigators
Principal Investigator: Veli-Jukka Anttila, MD,PhD,Docent HUCH
  More Information

No publications provided

Responsible Party: Mari Eriksson, MD, doctor of Infectious Diseases, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT01781871     History of Changes
Other Study ID Numbers: HUCH
Study First Received: November 22, 2012
Last Updated: January 30, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
Pneumococcal vaccination
immunogenicity
solid organ transplant

ClinicalTrials.gov processed this record on June 18, 2013