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

NCT ID: NCT01781871

Last Updated: 2017-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-10-04

Brief Summary

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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

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Conditions

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Kidney Transplantation Liver Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Prevenar13

Intervention Type BIOLOGICAL

Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.

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

Group Type ACTIVE_COMPARATOR

Pneumovax

Intervention Type BIOLOGICAL

0.5ml Pneumovax injected intramuscularly at day 1.

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.

Group Type EXPERIMENTAL

Prevenar13

Intervention Type BIOLOGICAL

Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.

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.

Group Type ACTIVE_COMPARATOR

Pneumovax

Intervention Type BIOLOGICAL

0.5ml Pneumovax injected intramuscularly at day 1.

Interventions

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Prevenar13

Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.

Intervention Type BIOLOGICAL

Pneumovax

0.5ml Pneumovax injected intramuscularly at day 1.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mari Eriksson

MD, doctor of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Veli-Jukka Anttila, MD,PhD,Docent

Role: PRINCIPAL_INVESTIGATOR

HUCH

Locations

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Helsinki University Central Hospital

Helsinki, HUS, Finland

Site Status

Heikki Saha

Tampere, , Finland

Site Status

Countries

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Finland

Other Identifiers

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HUCH

Identifier Type: -

Identifier Source: org_study_id