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OpenTrials
Completed

NCT Number: NCT01781871

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University Central Hospital, Helsinki, HUS, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prevenar13

Biological

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

Pneumovax

Biological

0.5ml Pneumovax injected intramuscularly at day 1.

Primary outcomes

  1. Change from baseline serum serotype specific immunoglobulin G (IgG) antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the first vaccination

    Time frame: baseline and 4 weeks after the first vaccination

  2. Change from baseline serum serotype specific IgG antibodies to 13 polysaccharides and their opsonophagocytic activity (OPA) after the second Prevenar vaccination

    Time frame: baseline and 4 weeks after the second vaccination

Secondary outcomes

  1. vaccination reactions

    Time frame: from vaccination upto 1 week

    Questionaire and phone interview assessment of vaccination reactions and adverse effects.

  2. rejection

    Time frame: at 1 and 2 months after the vaccination

    Urine analyses and creatinine measurement with kidney transplant patients. Alanine aminotransferase measurement with liver transplant patients.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Tampere University Hospital

Registry information

Official study 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

Acronym: SOT13

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2013
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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