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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01781871

Acronym

SOT13

Enrollment

182

Registered

2013-02-01

Start date

2013-01-31

Completion date

2017-10-04

Last updated

2017-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplantation, Liver Transplantation

Keywords

Pneumococcal vaccination, immunogenicity, solid organ transplant

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.

Interventions

BIOLOGICALPrevenar13

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

BIOLOGICALPneumovax

0.5ml Pneumovax injected intramuscularly at day 1.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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	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	baseline and 4 weeks after the second vaccination

Secondary

Measure	Time frame	Description
vaccination reactions	from vaccination upto 1 week	Questionaire and phone interview assessment of vaccination reactions and adverse effects.
rejection	at 1 and 2 months after the vaccination	Urine analyses and creatinine measurement with kidney transplant patients. Alanine aminotransferase measurement with liver transplant patients.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026