Immunogenicity of pneumococcal vaccine in liver transplant recipients

Completed

Conditions: Pneumococcal vaccination
Infections and Infestations
Vaccination

Registration Number: ISRCTN07731234

Lead Sponsor: niversity Health Network (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 130

Inclusion Criteria

Male or female outpatients who fulfill the following criteria will be eligible for the study:
1. Liver transplant recipients greater than three months post-transplant
2. No prior pneumococcal vaccination within the last five years
3. Stable allograft function as evidenced by a alanine aminotransferase less than 10 times the upper limit of normal (umol/L) that is not worsening
4. Able to provide written informed consent and comply with study protocol
5. Aged greater than 16 years

Exclusion Criteria

1. Unable to provide informed consent or comply with protocol
2. Prior pneumococcal vaccination within five years of enrolment
3. Splenectomy
4. Admitted to hospital for acute illness
5. Febrile illness in the past two weeks
6. Intravenous immunoglobulin in the last six months
7. Current episode of allograft rejection
8. Currently on full-dose anticoagulation as a contraindication to intramuscular injection

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody titres to the seven serotypes contained in conjugate vaccine (4, 6B, 9V, 14, 19F, 23F), 16 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Functional antibody concentration: the titre of functional antibody against the seven pneumococcal serotypes contained in the conjugate vaccine will be determined. <br>Opsonophagocytic assay will be measured at time 0 and 16 weeks.<br>2. Adverse reactions: any adverse effects attributed to conjugate or polysaccharide vaccines will be documented. These will include local reactions such as redness, swelling, tenderness and systemic reactions such as fever.<br>3. Invasive pneumococcal disease: any occurrence of documented pneumococcal disease in vaccinated patients will be recorded