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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01781871
First Posted: February 1, 2013
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Tampere University Hospital
Information provided by (Responsible Party):
Mari Eriksson, Helsinki University Central Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by Mari Eriksson, 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 ]
  • 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 Outcome Measures:
  • vaccination reactions [ Time Frame: from vaccination upto 1 week ]
    Questionaire and phone interview assessment of vaccination reactions and adverse effects.

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


Enrollment: 182
Study Start Date: January 2013
Study Completion Date: October 4, 2017
Primary Completion Date: October 4, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Biological: Prevenar13
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
Active Comparator: 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
Biological: Pneumovax
0.5ml Pneumovax injected intramuscularly at day 1.
Experimental: liver 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.
Biological: Prevenar13
Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
Active Comparator: liver 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.
Biological: Pneumovax
0.5ml Pneumovax injected intramuscularly at day 1.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01781871


Locations
Finland
Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029
Heikki Saha
Tampere, Finland, 33521
Sponsors and Collaborators
Helsinki University Central Hospital
Tampere University Hospital
Investigators
Principal Investigator: Veli-Jukka Anttila, MD,PhD,Docent HUCH
  More Information

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
First Submitted: November 22, 2012
First Posted: February 1, 2013
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Liver Extracts
Immunologic Factors
Physiological Effects of Drugs
Hematinics