- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781871
Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients (SOT13)
October 4, 2017 updated by: Mari Eriksson, Helsinki University Central Hospital
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
182
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tampere, Finland, 33521
- Heikki Saha
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HUS
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Helsinki, HUS, Finland, 00029
- Helsinki University Central Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
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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
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0.5ml Pneumovax injected intramuscularly at day 1.
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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.
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Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
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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.
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0.5ml Pneumovax injected intramuscularly at day 1.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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baseline and 4 weeks after the first vaccination
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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
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baseline and 4 weeks after the second vaccination
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
vaccination reactions
Time Frame: from vaccination upto 1 week
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Questionaire and phone interview assessment of vaccination reactions and adverse effects.
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from vaccination upto 1 week
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rejection
Time Frame: at 1 and 2 months after the vaccination
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Urine analyses and creatinine measurement with kidney transplant patients.
Alanine aminotransferase measurement with liver transplant patients.
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at 1 and 2 months after the vaccination
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Veli-Jukka Anttila, MD,PhD,Docent, HUCH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
October 4, 2017
Study Completion (Actual)
October 4, 2017
Study Registration Dates
First Submitted
November 22, 2012
First Submitted That Met QC Criteria
January 30, 2013
First Posted (Estimate)
February 1, 2013
Study Record Updates
Last Update Posted (Actual)
October 5, 2017
Last Update Submitted That Met QC Criteria
October 4, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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