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

Kidney Transplantation Clinical Trial

— SOT13  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01781871
• Other study ID #: HUCH
• Status: Completed
• Phase: Phase 4
• First received: November 22, 2012
• Last updated: October 4, 2017
• Start date: January 2013
• Est. completion date: October 4, 2017

Study information

• Verified date: October 2017
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: October 4, 2017
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation
• Liver Transplantation

Intervention

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

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki	HUS
Finland	Heikki Saha	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

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