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

NCT01781871 | Completed Phase 4 DMC

• 1 other identifier: HUCH
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 2

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.

Conditions

Kidney Transplantation; Liver Transplantation

Keywords

Pneumococcal vaccination; immunogenicity; solid organ transplant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• vaccination reactions

  from vaccination upto 1 week

• rejection

  at 1 and 2 months after the vaccination

Study Arms (4)

Prevenar13

EXPERIMENTAL

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

Biological: Prevenar13

Pneumovax

ACTIVE COMPARATOR

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

Biological: Pneumovax

liver Prevenar13

EXPERIMENTAL

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.

Biological: Prevenar13

liver Pneumovax

ACTIVE COMPARATOR

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.

Biological: Pneumovax

Interventions

Prevenar13 BIOLOGICAL

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

Prevenar13; liver Prevenar13

Pneumovax BIOLOGICAL

0.5ml Pneumovax injected intramuscularly at day 1.

Pneumovax; liver Pneumovax

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• consecutive new kidney or liver transplantation in our center
• kidney or liver retransplantation in our center

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Tampere University Hospital: collaborator

Study Sites (2)

Helsinki University Central Hospital

Helsinki, HUS, 00029, Finland

Location

Heikki Saha

Tampere, 33521, Finland

Location

MeSH Terms

Interventions

13-valent pneumococcal vaccine; Pneumococcal Vaccines

Intervention Hierarchy (Ancestors)

Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Veli-Jukka Anttila, MD,PhD,Docent

  HUCH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, doctor of Infectious Diseases

Study Record Dates

• First Submitted: November 22, 2012
• First Posted: February 1, 2013
• Study Start: January 1, 2013
• Primary Completion: October 4, 2017
• Study Completion: October 4, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

FI (2)