Clinical trial NCT01781871: Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine Compared to the Pneumococcal Polysaccharide Vaccine in Adult Kidney and Liver Transplant Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Transplantation
Liver Transplantation
Keywords: Pneumococcal vaccination
immunogenicity
solid organ transplant
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University Hospital
First posted: 2013-02-01
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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

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
timeFrame: baseline and 4 weeks after the first vaccination
measure: Change from baseline serum serotype specific IgG antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the second Prevenar vaccination
timeFrame: baseline and 4 weeks after the second vaccination
Secondary outcomes:
measure: vaccination reactions
timeFrame: from vaccination upto 1 week
measure: rejection
timeFrame: at 1 and 2 months after the vaccination
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: HUS
city: Tampere
country: Finland
facility: Heikki Saha
Study officials:
affiliation: HUCH
name: Veli-Jukka Anttila, MD,PhD,Docent
role: PRINCIPAL_INVESTIGATOR
References: